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Medtronic execs bullish on meeting growing demand for glucose sensors
Medtronic saw a shortfall in its supply of body-worn blood-glucose sensors amid demand that has more than doubled in two ...Learn More
AdvaMed hires director for first regional US office
Fielding Greaves was tapped by AdvaMed to be director of state government and regional affairs and will head up the group's ...Learn More
Exec: GI Dynamics committed to maintaining EndoBarrier device in market
GI Dynamics remains dedicated to keeping its EndoBarrier plastic gut sleeve on the market in spite of recent regulatory and ...Learn More
Funding round brings in $1.4M for Bone Biologics
A round of financing brought in $1.4 million for Bone Biologics, a Burlington, Mass.-based company that develops ...Learn More
Analysis predicts growth for US knee implant market
A Market Research Reports analysis predicts the US market for knee implants will see a 5.3% compound annual growth rate ...Learn More
Titan, French hospital reach deal on robotic surgical system studies
The Institut Hospitalo-Universitaire de Strasbourg in France agreed to become a partner site in the feasibility and ...Learn More
Cerebrotech eyes 2018 launch for wearable stroke test device
Pleasanton, Calif.-based Cerebrotech Medical Systems is looking to launch its Volumetric Integral Phase-shift Spectroscopy ...Learn More
Biotronik's self-expanding stent released by Getinge in the US
Biotronik's Pulsar-18 superficial femoral artery self-expanding stent was launched by Getinge, the US distributor of ...Learn More
Stackable guide wire debuted by CoreLink for SI joint fusion system
CoreLink announced the launch of its stackable guide wire, Scaltoff Wire, designed for its Entasis Sacroiliac Joint Fusion ...Learn More
FDA panel to hold meeting on pediatric HDE devices next month
The FDA's Pediatric Advisory Committee will convene Sept. ...Learn More
Start saving with the AdvaMed Purchasing Group
The AdvaMed Purchasing Group is a new member-only benefit that helps companies purchase the very best goods and services ...Learn More
A battle lost or won is easily described, understood and appreciated, but the moral growth of a great nation requires reflection, as well as observation, to appreciate it.
...Frederick Douglass, social reformer, abolitionist and orator
Veracity Innovations acquired by Carl Zeiss Meditec
Carl Zeiss Meditec paid an undisclosed amount for Veracity Innovations, a cloud-based ophthalmological technology developer. ...Learn More
Ind. medtech company gets $8M boost
Financing worth $8 million was secured by Carmel, Ind.-based medtech company FAST BioMedical from the NIH and a single ...Learn More
LabCorp reaches exclusive distribution deal with OmniSeq
An agreement was reached by Laboratory Corp. ...Learn More
Australian medtech company reaches partnerships in Singapore
Australian medtech firm Anatomics entered into a deal with Singapore's Nanyang Technological University to accelerate ...Learn More
US orthopedic small bone, joint devices market poised for growth
A series of reports from iData Research predicts the US market for orthopedic small bone and joint devices will hit $4 ...Learn More
How wearables will transform health care's future
Wearable technology is moving beyond consumer-grade health and wellness devices. ...Learn More
BioVentrix's transcatheter ventricular enhancement system gets IDE from FDA
The FDA has granted BioVentrix an investigational device exemption approval to conduct a trial evaluating the safety and ...Learn More
Ethicon announces launch of laparoscopic suturing device
The ProxiSure laparoscopic suturing device was released by Johnson & Johnson subsidiary Ethicon. ...Learn More
FDA clears Creo's Speedboat RS2 endoscopic device, CROMA platform
The FDA gave Creo Medical Group 510(k) clearance for the Speedboat RS2 device and the CROMA platform 49 days after the ...Learn More
Biotronik's MR-conditional CRT pacemaker wins FDA nod
Biotronik obtained approval from the FDA for its Edora HF-T QP magnetic resonance-conditional quadripolar cardiac ...Learn More
EU OKs left heart lead from Medtronic
European regulators have given Medtronic CE mark approval for its Attain Stability Quad MRI SureScan left heart lead, a ...Learn More
One of the most important lessons I learned in business was that if all you're getting from your team is a single point of view -- usually your point of view -- you've got to worry. You can get your own point of view for free.
...Lee Iacocca, auto executive
Offering could pull in $25M for Senseonics
An offering of 11.6 million shares has been priced by Senseonics in hopes of raising about $25 million. ...Learn More
DOD taps MinXray for $100M radiology supplies contract
The Department of Defense awarded Northbrook, Ill.-based MinXray a five-year contract worth up to $100 million to provide ...Learn More
Inrad partners with Mich. medical device contract manufacturer
Kentwood, Mich.-based Inrad has entered into a partnership with Grand Rapids, Mich.-based medical device contract ...Learn More
Analysis predicts growth for global wearable medical devices market
A MarketStudyReport.com analysis predicts the worldwide market for wearable medical devices will see a 9.46% compound annual ...Learn More
Global orthopedic surgical navigation systems market poised for growth
A MarketResearchNest analysis predicts the worldwide market for orthopedic surgical navigation systems will see a 7.21% ...Learn More
Study finds drop in pulmonary artery catheter use among Medicare patients
A study in JAMA Cardiology found the rate of pulmonary artery catheter use per 1,000 hospital admissions among Medicare ...Learn More
New-gen drug-eluting stents show positive outcomes for women with acute MI
A study in JAMA Cardiology found that the use of new-generation drug-eluting stents, including biolimus- and ...Learn More
FDA clears Glytec's diabetes management system
The FDA granted Glytec 510(k) clearance for its Glucommander diabetes management system. ...Learn More
User fee reauthorization bill becomes law
A bill that reauthorizes the FDA's user fee program for medical devices, drugs and biosimilars was signed into law by ...Learn More
FDA's serological panel offered to Zika assay developers to ensure reliability
A panel of plasma samples was developed by the FDA to help developers of serological Zika assays ensure that their products ...Learn More
MedTech Quality Workshop
Nov. ...Learn More
He that is overcautious will accomplish little.
...Friedrich Schiller, writer and historian
Public offering pulls in $18.1M for EnteroMedics
A public offering of Series B convertible preferred stock and stock purchase warrants has brought in $18.1 million for ...Learn More
Roka Bioscience enters $17.5M deal to sell assets to IEH unit
A $17.5 million all-cash agreement has been reached by Roka Bioscience to sell substantially all of its assets to newly ...Learn More
Private placements could bring in $4.3M for DarioHealth
Private placements of Series B convertible preferred stock and common stock could pull in $4.3 million for DarioHealth. ...Learn More
Elidah eyes $2M in additional funds for stress urinary incontinence device
Monroe, Conn.-based Elidah is looking to obtain up to $2 million in additional proceeds after securing up to $750,000 in ...Learn More
Report predicts growth for global minimally invasive spine surgery market
An Absolute Reports analysis predicts the worldwide minimally invasive spine surgery market will see a compound annual ...Learn More
Chief financial officer to retire from Chembio
Richard Larkin will retire as chief financial officer of Chembio Diagnostics by the end of the year. ...Learn More
Palmetto, Anthem to cover use of Myriad's breast cancer recurrence test
Myriad Genetics obtained positive coverage decisions from Anthem and Medicare contractor Palmetto GBA for its EndoPredict ...Learn More
Data show positive results for Endologix's endografts
Preliminary data from a 458-patient study showed Endologix's AFX and AFX2 endografts demonstrated an 84.7% rate of freedom ...Learn More
HeartSciences announces EU approval, launch of MyoVista hsECG
European regulators gave HeartSciences CE mark approval for its MyoVista high sensitivity electrocardiograph testing device, ...Learn More
FDA clears Globus Medical's robotic guidance, navigation system
The FDA granted Globus Medical clearance to market its robotic guidance and navigation platform, Excelsius GPS, which is ...Learn More
8th Annual Advertising and Promotion of Medical Devices Conference
Nov. ...Learn More
There is no waste of any kind in the world that equals the waste from needless, ill-directed and ineffective motions.
...Frank Bunker Gilbreth, engineer
Senior notes offering could pull in $1.2B for LabCorp
A two-tranche offering of 3.25% senior notes due in 2024 and 3.6% senior notes due in 2027 has been priced by Laboratory ...Learn More
Funding round pulls in $12M for ReCor Medical
A round of debt financing involving Otsuka Pharmaceutical brought in $12 million for ReCor Medical, company President and ...Learn More
Iowa medical robotics startup gets $2M boost
A round of seed financing pulled in $2 million for medical robotics startup iotaMotion, a spinout of the University of ...Learn More
Royal Philips, Lakeland Health enter deal on patient monitoring
An agreement was reached by Royal Philips with St. ...Learn More
Analysis predicts growth for global next-gen implants market
A BIS Research analysis predicts the worldwide market for next-generation implants will reach $3.9 billion by 2023, up from ...Learn More
Report: Worldwide sports medicine market poised for growth
A Data Bridge Research report predicts the global sports medicine market will reach $34.7 billion by 2024 at an 8.9% ...Learn More
Study examines quality of data supporting PMA supplements for medtech
A study in the Journal of the American Medical Association found the approval of panel-track supplements for several medical ...Learn More
FDA clears pedicle screw from Stryker Spine
The FDA granted Stryker Spine clearance for its Serrato Pedicle Screw, a component of the Xia 3 Spinal System used by ...Learn More
India orders price caps for knee implants
India's National Pharmaceutical Pricing Authority issued an order to cap prices of total knee replacement systems and their ...Learn More
Recall of Cook Medical's thoracic endovascular graft labeled Class I by FDA
A recall initiated by Cook Medical involving its Zenith Alpha thoracic endovascular graft was classified by the FDA as Class ...Learn More
Cybersecurity Summit
Nov. 2 | Washington, D.C.The AdvaMed Cybersecurity Summit brings together experts across the device security spectrum. ...Learn More
The mode in which the inevitable comes to pass is through effort.
...Oliver Wendell Holmes Jr., jurist
Funding round pulls in $15M for VentureMed
A round of Series B financing brought in $15 million for Toledo, Ohio-based VentureMed Group, a maker of endovascular ...Learn More
Abbott, North West London Pathology enter into $252M services contract
North West London Pathology signed a $252 million managed equipment services contract with Abbott for the supply of North ...Learn More
Biofortuna raises $2.1M in funding round
A round of funding pulled in approximately $2.1 million for Biofortuna, developer of the ReadyPlex rapid blood group ...Learn More
Siemens, Houston Methodist Hospital reach supply, R&D agreement
A multiyear deal was signed by Siemens Healthineers and Houston Methodist Hospital to collaborate in research and ...Learn More
New executive VP, CFO named by NuVasive
Rajesh Asarpota was tapped to serve as executive vice president and chief financial officer at NuVasive effective Sept. 1. ...Learn More
Vascular Dynamics' hypertension device gets IDE from FDA
The FDA gave Vascular Dynamics an investigational device exemption to conduct a 300-patient trial of its MobiusHD device, ...Learn More
Trial begins for Tandem Diabetes' insulin pump with predictive algorithm
A 90-patient, six-site pivotal trial was initiated by Tandem Diabetes to evaluate its t:slim X2 Pump with a predictive low ...Learn More
FDA clears BioStable's HAART 200 aortic annuloplasty device
The FDA gave BioStable Science & Engineering clearance to market its HAART 200 aortic annuloplasty device, which is ...Learn More
Whitaker: Permanent repeal of medical device tax should be Congress' priority
Congress should immediately act to permanently repeal the medical device tax, or thousands of companies could face a tax ...Learn More
Camber Spine's ALIF device wins FDA clearance
Camber Spine Technologies' SPIRA Open Matrix anterior lumbar interbody fusion device was granted clearance by the FDA. ...Learn More
MedTech Coverage, Coding, & Reimbursement 201 Workshop
Oct. ...Learn More
A prosperous fool is a grievous burden.
...Aeschylus, playwright
Thermo Fisher Scientific gets $1.5B boost
A 364-day unsecured term loan facility worth $1.5 billion was secured by Thermo Fisher Scientific. ...Learn More
Tender offer for Alere preferred stock extended by Abbott
A cash tender offer for all outstanding shares of Alere's Series B convertible perpetual preferred stock has been extended ...Learn More
Deal to sell 2.5M shares announced by Oxford Immunotec
A deal to sell 2.5 million ordinary shares was reached by diagnostic company Oxford Immunotec with investment bank BTIG. ...Learn More
Dune Medical announces HQ relocation to Ga.
Dune Medical Devices announced the relocation of its US headquarters from Paoli, Pa., to Alpharetta, Ga., which is expected ...Learn More
Report predicts growth for global hybrid OR market
A Marketsandmarkets report predicts the worldwide hybrid operating room market will hit $1.175 billion by 2022 at a 12.5% ...Learn More
Serious medtech recalls nearly doubled in Q2
Medical device recalls at the Class I level were up 88%, and the major culprit was quality issues, according to Stericycle ...Learn More
Apollo, Reshape release statements amid FDA alert on balloon-related deaths
Apollo Endosurgery, as part of its Global Product Surveillance program, self-reported the deaths that an FDA alert said were ...Learn More
Medtronic study to evaluate dual anti-platelet therapy outcomes for DES
A randomized clinical trial was initiated by Medtronic to assess a one-month course of treatment that includes a combination ...Learn More
Abbott releases contact force ablation catheter in select European markets
The TactiCath contact force ablation catheter, a combination of the Endosense device and the EnSite Precision cardiac ...Learn More
FDA clears ImpediMed's bioimpedance spectroscopy platform
The FDA granted ImpediMed 510(k) clearance for its Sozo bioimpedance spectroscopy platform, a system intended to be used ...Learn More
Renovis Surgical's 3D-printed interbody fusion systems win FDA clearance
Renovis Surgical Technologies' 3D-printed Tesera porous titanium interbody fusion systems have been granted 510(k) clearance ...Learn More
MedTech Coverage, Coding, & Reimbursement 101 Workshop
Oct. ...Learn More
Happiness is the consequence of personal effort.
...Elizabeth Gilbert, writer
Senior notes offering could pull in $1.5B for Thermo Fisher Scientific
An offering of 3.2% senior notes due in 2027 and 4.1% senior notes due in 2047 has been priced by Thermo Fisher Scientific ...Learn More
3-for-1 stock split approved by Intuitive Surgical's board
A 3-for-1 common stock split received approval from Intuitive Surgical's board of directors and will be put to the company's ...Learn More
EnteroMedics looks to raise $20M in public offering
An underwritten public offering of Series B convertible preferred stock and stock purchase warrants was priced by ...Learn More
Viveve, InControl Medical reach exclusive distribution deal
InControl Medical granted Viveve Medical exclusive rights to distribute its products in the US under an agreement that ...Learn More
CEO gives updates on Senseonics' activities
Senseonics is moving forward with the expansion of its European operations, generating higher sales in the region this ...Learn More
Study shows positive results for robot-assisted transhiatal esophagectomy
A 100-patient study published in the journal Diseases of the Esophagus found robot-assisted transhiatal esophagectomy ...Learn More
Novel Zika assay uses nanotechnology to deliver results in minutes
Washington University in St. ...Learn More
Scientists create TRI-Analyzer to transform smartphone into diagnostic device
A transmission-reflectance-intensity-Analyzer was developed by researchers at the University of Illinois at Urbana-Champaign ...Learn More
Bionix brachytherapy applicators to be marketed by Varian in North America
Varian Medical Systems reached a deal with Bionix Radiation Therapy to market and distribute Bionix's disposable ...Learn More
EU issues draft lists for notified body designation under IVD, device rules
Two draft lists that contain 171 codes for specifying notified bodies' scope of designation under the EU medical device and ...Learn More
There is no such thing on earth as an uninteresting subject; the only thing that can exist is an uninterested person.
...G.K. Chesterton, writer and critic
Stryker's $700M acquisition of Novadaq gains approval from Canadian court
A final order has been issued by the Ontario Superior Court of Justice approving Stryker's acquisition of fluorescence ...Learn More
Funding round pulls in $13M for NeoSync
A round of Series D financing has brought in $13 million for Boston-based clinical-stage firm NeoSync. ...Learn More
InVivo swaps warrants for common stock in $2.4M exchange
A $2.4 million exchange of outstanding warrants for 2 million new shares of common stock has been announced by InVivo ...Learn More
Private placement could bring in $2.2M for Biocept
A private placement of common stock and warrants involving Hong Kong-based investment group Ally Bridge LB Healthcare Master ...Learn More
JustRight, Intuitive Surgical reach licensing deal
An agreement has been reached by JustRight Surgical with Intuitive Surgical granting Intuitive an exclusive global license ...Learn More
New VP of investor relations named by Varian Medical Systems
J. Michael Bruff has been tapped to serve as vice president of investor relations at Varian Medical Systems. ...Learn More
Warning on deaths after intragastric balloons implantation issued by FDA
A letter was released by the FDA alerting health care providers of seven deaths involving patients implanted with ...Learn More
Data show positive results for Cardiovascular Systems' DiamondBack 360 system
Results from a trial presented at the annual Amputation Prevention Symposium showed use of peripheral interventions, ...Learn More
Bloodstream infection system, assay from iCubate win FDA clearance
The FDA has given molecular diagnostics firm iCubate clearance for the iC-System and the iC-GPC assay for rapid detection of ...Learn More
AdvaMed looks to win device tax repeal in Congress' remaining agenda
AdvaMed is looking to use this year's remaining congressional agenda, including the reauthorization of the Children's Health ...Learn More
Few men during their lifetime come anywhere near exhausting the resources dwelling within them. There are deep wells of strength that are never used.
...Richard Byrd, naval officer and explorer
$24B Becton Dickinson merger secures C.R. Bard shareholder approval
A merger deal between Becton Dickinson and C.R. Bard, valued at $24 billion, received approval from C.R. ...Learn More
Royal Philips closes $2.2B deal to buy Spectranetics
The $2.2 billion acquisition of Spectranetics was completed by Royal Philips, making Spectranetics a part of its ...Learn More
Thermo Fisher Scientific sets share price in $1.5B public offering
Thermo Fisher Scientific said its underwritten public offering of approximately 8.77 million shares of common stock was ...Learn More
$30M deal to acquire CellRight completed by Tissue Regenix
The approximately $30 million acquisition of CellRight Technologies, along with its spinal surgery and orthopedic portfolio, ...Learn More
ConforMIS announces $6.5M purchase of assets from Broad Peak
ConforMIS has paid about $750,000 in common stock and $5.75 million in cash for machining and polishing assets from Broad ...Learn More
Preceptis Medical looks to raise $1M in offering
An offering of senior convertible promissory notes and warrants was filed by Plymouth, Minn.-based Preceptis in hopes of ...Learn More
Trial begins for Abbott's transcatheter tricuspid repair device
The first patient in a trial of Abbott's minimally invasive, clip-based transcatheter valve repair system for the treatment ...Learn More
Stimwave's MRI-compatible neuromodulation device wins FDA clearance
The FDA has given Stimwave Technologies clearance to market its StimQ Peripheral Nerve Stimulator System, a wireless ...Learn More
AdvaMed ad campaign calls for permanent medical device tax repeal
A digital and social media advertising campaign was launched by AdvaMed to call for the permanent repeal of the medical ...Learn More
FDA clears In2Bones' foot fracture, correction systems
In2Bones Global obtained clearance from the FDA to market its CoLag Locking Compression Screw System and 5MS Fracture Repair ...Learn More
I think a hero is an ordinary individual who finds the strength to persevere and endure in spite of overwhelming obstacles.
...Christopher Reeve, actor and director
Public offering could pull in $1.5B for Thermo Fisher Scientific
An underwritten public offering of common stock was launched by Thermo Fisher Scientific in hopes of raising $1.5 billion. ...Learn More
Osprey obtains $17.3M in oversubscribed offering
An oversubscribed offering of about 55.5 million Chess Depositary Interests pulled in approximately $17.3 million for Osprey ...Learn More
Oxford Finance provides $15M debt financing to AirXpanders
Debt financing worth $15 million has been secured by Palo Alto, Calif.-based AirXpanders from Oxford Finance. ...Learn More
Hemex, Tata Elxsi team up on malaria, sickle cell test development
India-based Tata Elxsi has been tapped by Hemex Health to be its product design and engineering partner in the development ...Learn More
Analysis: Q2 health care M&A activity led by medical device sector
A PwC Health Research Institute analysis found the medical device sector led health care in mergers and acquisitions ...Learn More
BCBS health plans issue positive coverage decisions for HeartFlow's FFR-CT
HeartFlow obtained positive medical policies from Horizon Blue Cross Blue Shield of New Jersey, Blue Cross of Idaho, Blue ...Learn More
First use of HD radiotherapy system recorded by Varian Medical
A patient at Italy's Sacro Cuore Don Calabria Cancer Care Center was the first to undergo treatment using the HyperArc ...Learn More
FDA clears Minn. startup's heart murmur detection device
The FDA gave Minnesota-based startup AUM Cardiovascular clearance to market its CADence System, a hand-held digital ...Learn More
Warning on Abbott's bioresorbable stents issued by Indian drug regulator
India's drug regulator issued a warning against Abbott India's bioresorbable stents used in blood vessels that measure up to ...Learn More
Standard Bariatrics' laparoscopic surgical clamp wins FDA clearance
The FDA granted Standard Bariatrics clearance for its Standard Clamp, a disposable laparoscopic surgical clamp designed to ...Learn More
It is a fool's prerogative to utter truths that no one else will speak.
...Neil Gaiman, writer
Fresenius to acquire NxStage in $2B deal
Fresenius Medical Care of Germany said it agreed to purchase Boston-based home dialysis equipment maker NxStage Medical for ...Learn More
N.C. ophthalmalogical device maker to be acquired by J&J Vision
Johnson & Johnson's Vision business has agreed to pay an undisclosed amount for North Carolina-based TearScience, which ...Learn More
Financing round pulls in $20M for Neuros Medical
A round of Series AA venture capital financing involving Boston Scientific has brought in $20 million for Willoughby Hills, ...Learn More
CeloNova reaches financing deal with SWK, Congruent
A four-year financing deal was reached by CeloNova BioSciences with SWK Holdings and Congruent Investment Partners. ...Learn More
DePuy Synthes, Medical Enterprises enter co-marketing agreement
Johnson & Johnson subsidiary DePuy Synthes agreed to exclusively co-market Medical Enterprises Distribution's ME1000 ...Learn More
Bioventus announces leadership changes
Bioventus promoted its chief accounting officer, Greg Anglum, to senior vice president and chief financial officer. ...Learn More
Integer Holdings: What you need to know
Greatbatch and Lake Region Medical merged nearly two years ago to become Integer Holdings, a giant medical device contract ...Learn More
Data show positive results for Boston Scientific's S-ICD
Midterm outcomes from a 1,000-patient, 42-site trial, published in the Journal of the American College of Cardiology, found ...Learn More
Siemens to issue security update for some PET scanners this month
A spokesman for Siemens said Monday that the company will release a software update for Microsoft Windows 7-based versions ...Learn More
Novel tech can regenerate damaged tissue from tiny patch
A technology called tissue nanotransfection uses nanochips to reprogram skin cells in a damaged area, allowing regeneration ...Learn More
FDA clears Mauna Kea's UHD confocal miniprobes
The FDA gave Mauna Kea 510(k) clearance for its CelioFlex UHD confocal miniprobes, which provide visualization of body ...Learn More
Inspiration is never genuine if it is known as inspiration at the time. True inspiration always steals on a person.
...Samuel Butler, writer
RTI Surgical's cardiothoracic business sold to A&E in $60M deal
Vance Street Capital portfolio company A&E Advanced Closure Systems acquired RTI Surgical's cardiothoracic closure business, ...Learn More
Funding round brings in $280.2M for Auris Surgical
A round of Series D financing involving 39 investors pulled in $280.2 million for San Carlos, Calif.-based Auris Surgical ...Learn More
Securities offering could pull in $2.7M for Rosetta Genomics
A public offering of 1.9 million securities units has been priced by Rosetta Genomics in hopes of raising about $2.7 ...Learn More
ProLung looks to raise $8M in IPO
Salt Lake City-based ProLung filed an initial public offering with the goal of raising up to $8 million. ...Learn More
Mich. medtech startup raises $1M-plus in funding round
A round of financing brought in $1.125 million for Holland, Mich.-based medical device startup Genesis Innovation Group, ...Learn More
Nuo Therapeutics drops plans to go public
Gaithersburg, Md.-based Nuo Therapeutics filed to withdraw its proposed $11 million initial public offering of 2.1 million ...Learn More
LivaNova, Edwards Lifesciences score reimbursement win for aortic valves
Rapid deployment valves, including Edwards Lifesciences' Intuity and LivaNova's Perceval aortic valves, have obtained new ...Learn More
FDA clears 3T MRI scanner from GE
The FDA granted GE Healthcare 510(k) clearance for its SIGNA Premier 3.0 Tesla MRI scanner, a wide-bore system produced ...Learn More
DHS advisory: 4 Siemens imaging systems may be prone to cyberattacks
An advisory issued by the Department of Homeland Security and Siemens Healthineers identifies cybervulnerabilities in the ...Learn More
Getinge units' balloon pump recall labeled Class I by FDA
A recall initiated by Getinge subsidiaries Datascope and Maquet involving 9,194 units of CS100i, CSO100 and CS300 ...Learn More
If you don't know where you're going, you might not get there.
...Yogi Berra, baseball player and manager
Siemens eyes listing of health care business in first half of 2018
Siemens announced that it will list its health care business through a $47 billion initial public offering in the first half ...Learn More
UltraLinq buys Irish developer of vital signs monitoring devices
New York-based UltraLinq has paid an undisclosed amount for Ulster University spinout Intelesens, an Irish medtech company ...Learn More
Swiss robotic developer acquired by Globus Medical
Globus Medical said it closed its acquisition of Swiss robotic developer KB Medical in the second quarter of 2017, during ...Learn More
Integrity Applications obtains $12M in private placement
Wilmington, Del.-based Integrity Applications completed a private placement offering, bringing in $12 million in total ...Learn More
Private placement brings in $8.5M for Quanterix
A private placement led by T. Rowe Price has pulled in $8.5 million for Quanterix. ...Learn More
Clerkin to resign as CFO of ConvaTec
Nigel Clerkin will resign as chief financial officer of ConvaTec after the company decided to relocate the role to its main ...Learn More
Health Care Service Corp. divisions update MIS joint fusion policy
Effective July 15, Health Care Service Corp.'s Blue Cross Blue Shield divisions in Illinois, New Mexico, Oklahoma, Montana ...Learn More
Milwaukee company to develop commercial version of cancer detection device
A commercial version of MarginScan, a device that detects cancerous cells using an impedance technology, will be developed ...Learn More
Senate reauthorizes FDA user fees
The Senate voted 94-1 in favor of legislation renewing the FDA's authority to collect user fees from drug and device makers. ...Learn More
FDA authorizes emergency use of Thermo Fisher's Zika testing kit
Thermo Fisher Scientific obtained FDA emergency use authorization for its TaqPath Zika Virus Kit for use in qualitative ...Learn More
What is a weed? A plant whose virtues have not yet been discovered.
...Ralph Waldo Emerson, writer
ALung Technologies raises $37.42M in funding round
A round of equity financing garnered $37.42 million for Pennsylvania-based Alung Technologies. ...Learn More
Oxford Finance provides $40M amended credit facility to Cerus
Cyrus secured an amended growth capital credit facility worth $40 million from Oxford Finance. ...Learn More
Mayo Clinic reaches collaboration with Minn. medtech startup
The Mayo Clinic and Minnesota-based medtech startup NeuroOne have entered into a relationship that includes an extensive ...Learn More
Ortho, Thermo Fisher's BRAHMS partner on PCT assay development
Ortho Clinical Diagnostics and Thermo Fisher Scientific's BRAHMS announced a strategic relationship aimed at developing the ...Learn More
Q3 revenue increases for Hologic
Hologic generated $806.1 million in revenue in the three months ending July 1, a 12% year-over-year growth driven by the ...Learn More
Stryker elects new director
Mary Brainerd has been elected to the board of directors of Stryker. ...Learn More
Laminate Medical's fistula support device gets IDE from FDA
The FDA has given Laminate Medical Technologies investigational device exemption approval to conduct a 13-site, 129-patient ...Learn More
Keystone plans clinical testing of 3rd-gen embolic protection device
Israel-based Keystone Heart said it intends to initiate trials of its TriGuard 3 third-generation cerebral embolic ...Learn More
FDA, EU approve Medtronic's pericardial aortic surgical valve
The FDA approved Medtronic's Avalus pericardial aortic surgical valve, which is indicated for treating aortic-valve disease. ...Learn More
FDA OKs photocoagulator from Quantel Medical
Quantel Medical secured FDA approval for its Easyret device, a photocoagulator designed to treat macular edema and ...Learn More
You are your possibilities. If you know that, you can do anything.
...Oprah Winfrey, media personality, businesswoman and philanthropist
CytoBioScience, Skyline Medical sign merger agreement
San Antonio-based startup CytoBioScience signed a letter of intent to form a merger with Skyline Medical, an Eagan, ...Learn More
Profound completes $6M deal to buy Philips' Sonalleve MR-HIFU business
Profound Medical closed its purchase of Royal Philips' Sonalleve MR-HIFU business, valued at $6 million. ...Learn More
Funding round pulls in $7M for Shape Memory Medical
A round of equity financing involving 15 unnamed investors has garnered $7 million for Santa Clara, Calif.-based Shape ...Learn More
CoreMedic secures capital for heart-valve repair technologies
SHS Gesellschaft fur Beteiligungsmanagement invested an undisclosed amount in CoreMedic, a heart valve-repair startup based ...Learn More
KPMG survey examines cybersecurity concerns of medtech, drug companies
Eighty-two percent of 100 information technology and information security officers at US medical device and drug companies ...Learn More
Preliminary data show positive results for W.L. Gore's Viatorr Tips with CE
Preliminary data from a trial presented at the International Liver Congress 2017 showed W.L. ...Learn More
Siemens garners Canadian approval for 3-tesla MRI system
Health Canada granted Siemens Healthineers clearance to market the Magnetom Vida 3-tesla MRI system, which comes with the ...Learn More
India's mandatory MRP inclusion on medtech packages to take effect Jan. 1
The Indian government on Tuesday informed Parliament that the mandatory inclusion of maximum retail price on packages of ...Learn More
Xavant's noninvasive neuromodulation device wins FDA clearance
Xavant Technology obtained FDA clearance for its Stimpod NMS460, a noninvasive neuromodulation device designed for ...Learn More
EU expands MRI safety labeling for LivaNova's VNS systems
European regulators have given LivaNova CE Mark approval for expanded MRI safety labeling of the company's Vagus Nerve ...Learn More
Too much rest is rust.
...Sir Walter Scott, writer
Cantel Medical reaches $60.8M deal to buy German endoscope reprocessor
Cantel Medical reached a definitive agreement to pay $60.8 million for BHT Hygienetechnik Holding, an automated endoscope ...Learn More
Invitae announces $73.5M stock sale, acquisitions of Good Start, CombiMatrix
Invitae announced that it is acquiring Good Start Genetics and CombiMatrix under deals that add reproductive health testing ...Learn More
Funding boost secured by Otomagnetics
A round of funding brought in an undisclosed amount for Otomagnetics, a University of Maryland spin-out that is developing a ...Learn More
Sepsis-focused medtech startup launched in Tenn.
Startup PathEX, which is developing a device for capturing bloodborne bacteria to diagnose and treat sepsis, debuted in ...Learn More
VP of clinical affairs named by SetPoint Medical
Terry Bevirt has been tapped to serve as vice president of clinical affairs at SetPoint Medical. ...Learn More
InVivo suspends enrollment in Neuro-Spinal Scaffold trial
InVivo Therapeutics has suspended enrollment in a trial evaluating its Neuro-Spinal Scaffold for treatment of complete ...Learn More
1st micro-laparoscopic robotic surgeries recorded for TransEnterix's Senhance
Patients at Rome's Policlinico A. ...Learn More
Medtronic debuts CoreValve Evolut PRO valve in Europe
Medtronic is launching its CoreValve Evolut PRO transcatheter aortic valve in Europe after receiving CE mark approval from ...Learn More
CardioFocus' endoscopic ablation system wins Japanese approval for Afib
The Japanese Ministry of Health, Labor and Welfare has granted CardioFocus approval for its HeartLight endoscopic ablation ...Learn More
EU approves Thermo Fisher's real-time PCR system
European regulators have granted Thermo Fisher Scientific CE-IVD marking for the QuantStudio 5 Dx Real-Time PCR system, ...Learn More
The most painful moment in my life also became the moment I showed the most strength and courage.
...Cecelia Ahern, writer
Cardinal Health finalizes $6.1B deal to acquire certain Medtronic assets
The acquisition of Medtronic's Patient Care, Deep Vein Thrombosis and Nutritional Insufficiency business, valued at $6.1 ...Learn More
LongueVue Capital announces acquisition of Zavation Medical
Zavation Medical Products, a company that designs and makes spinal implants, biologics and instruments, was acquired by ...Learn More
Offering pulls in around $7M for Titan Medical
A two-tranche stock offering garnered approximately $7 million for Titan Medical. ...Learn More
NuVasive announces organizational restructuring, leadership changes
NuVasive announced that it is restructuring to achieve strategic goals, including a scalable worldwide commercial ...Learn More
Boston Scientific to drop bioplastic-stent development program
Boston Scientific will abandon its long-running program to develop Renuvia, a biodegradable plastic stent, despite promising ...Learn More
Quantitative Insights' computer-aided diagnosis system wins FDA clearance
Quantitative Insights secured clearance from the FDA to market its QuantX Advanced system to evaluate breast abnormalities. ...Learn More
AliveCor to offer wireless EKG device to Prairie Cardiovascular patients
AliveCor will offer its Kardia Mobile device to patients of Prairie Cardiovascular starting in August under its partnership ...Learn More
AdvaMed geared up for next medical-device tax-repeal vehicle
AdvaMed intends to work with Congress to find the fastest way of ending the medical-device tax, possibly through the ...Learn More
Australia seeks feedback on proposed medtech regulations
Australia's Therapeutic Goods Administration has proposed the reclassification of surgical meshes from class IIb to class ...Learn More
FDA clears plasmapheresis system from Haemonetics
The FDA has granted Haemonetics 510(k) clearance for its NexSys PCS plasmapheresis system, intended for blood plasma ...Learn More
There exists in the world a single path along which no one can go except you: whither does it lead? Do not ask, go along it.
...Friedrich Nietzsche, philosopher
Funding round pulls in $50M for Entellus Medical
A round of equity financing involving 45 anonymous investors has brought in $50 million for Entellus Medical, according to a ...Learn More
Boston Scientific seeks growth in minimally invasive aortic valves
Boston Scientific intends to file an application with the FDA for approval of its Lotus valve system by year's end, one of ...Learn More
CasMed's non-invasive BP monitoring product line sold to SunTech for $4.5M
SunTech Medical has acquired CAS Medical System's non-invasive blood pressure monitoring product line, which includes the ...Learn More
Seed funding round brings in $844K for stimOS
A round of seed funding has brought in around $844,000 for stimOS, a German company that has created a biochemical procedure ...Learn More
Qiagen, HTG Molecular announce 2nd development program
A second development program has been launched by Qiagen and HTG Molecular Diagnostics under a master assay development, ...Learn More
First half underlying revenue increases for Smith & Nephew
Smith & Nephew generated approximately $2.34 billion in underlying revenue during the first half of the year, a 3% increase. ...Learn More
Interpace's molecular thyroid test scores reimbursement win
Cigna has agreed to cover Interpace Diagnostics' ThyGenX molecular thyroid test, a next-generation sequencing test that ...Learn More
Feature set on Agfa's XERO Universal Viewer cleared by FDA
The FDA has granted Agfa HealthCare its 510(k) clearance for the XERO Xtend functionalities on its Enterprise Imaging ...Learn More
Senate rejects GOP's scaled-down ACA repeal
In a 49-51 vote, the Senate rejected a measure known as the Health Care Freedom Act that would have repealed the Affordable ...Learn More
Gottlieb unveils details on FDA's plans for digital health regulation
The FDA's pilot program for pre-certification of software-based medical devices, which will begin in September with up to ...Learn More
For more:
...Read AdvaMed's statement on the FDA's Digital Health Innovation Action Plan and Pre-Certification Software Pilot Program.
Apathy can't be an excuse for inaction.
...Bill Bradley, basketball player and politician
Genesis Medical acquired by Cogentix Medical
Cogentix Medical has announced its acquisition of Genesis Medical, the exclusive UK distributor of its PrimeSight endoscopy ...Learn More
Offering pulls in $36M for Apollo Endosurgery
A public offering of around 6.54 million shares of common stock has brought in $36 million for Apollo Endosurgery. ...Learn More
Signature Medical obtains $2.5M in funding round
A round of Series A financing has pulled in $2.5 million for Signature Medical, an Allied Minds portfolio company that makes ...Learn More
EnteroMedics, Verily-GSK joint venture enter partnership deal
EnteroMedics has agreed to allow the use of a modified vBloc system for pre-clinical research by Galvani Bioelectronics, a ...Learn More
Visia Imaging reaches commercialization deal with Bio-Rad
Visia Imaging has agreed to give Bio-Rad Laboratories commercialization rights to its second-generation immunofluorescence ...Learn More
First Russian procedure using Argus II system recorded by Second Sight Medical
A patient at the Federal State Institution & Clinical Research Center of the Federal Medico-Biological Agency in Moscow was ...Learn More
Surmodics's next-gen drug-coated balloon gets IDE from FDA
Surmodics has obtained an investigational device exemption from the FDA to conduct a pivotal clinical trial of its SurVeil ...Learn More
Canada OKs Medtronic's line of MRI-conditional CRT-Ds
Health Canada has given Medtronic Canada approval for its line of MRI-conditional cardiac resynchronization therapy ...Learn More
Senate rejects broad ACA repeal legislation
The Senate voted down a measure proposed by Sen. ...Learn More
Spectranetics' drug-coated balloon wins FDA approval
The FDA has given Spectranetics approval for its Stellarex drug-coated balloon, a device intended for use in treating ...Learn More
Don't judge each day by the harvest you reap but by the seeds that you plant.
...Robert Louis Stevenson, writer
DiaSorin reaches $55.3M deal to acquire Siemens' ELISA business
DiaSorin has agreed to pay $55.3 million on a debt- and cash-free basis for Siemens Healthineers' microtiter-based ELISA ...Learn More
J&J medical device division announces new neurovascular business
The medical device division of Johnson & Johnson unveiled its neurovascular business, Cerenovus, at the annual meeting of ...Learn More
Rebound Therapeutics gets $16.5M boost
Irvine, Calif.-based Rebound Therapeutics raised $16.5 million in a round of Series B financing. ...Learn More
Exercise of warrants brings in $5.74M for OncoCyte
OncoCyte secured $5.74 million after certain warrant holders exercised around 1.77 million common stock purchase warrants. ...Learn More
Funding round brings in $4.5M for Okami Medical
A round of Series B financing by Aliso Viejo, Calif.-based medtech company incubator Inceptus Medical pulled in $4.5 million ...Learn More
Abbott, Roxwood Medical enter exclusive distribution deal
Abbott has signed a deal with Roxwood Medical for exclusive US distribution of the latter's anchoring catheters and ...Learn More
Roche's HIV-1/HIV-2 test added to Global Access Program
Roche's Global Access Program, an initiative that seeks to eradicate the HIV/AIDS epidemic, will include the company's Cobas ...Learn More
Takeda, BioSurfaces to develop medical devices for GI diseases
Takeda Pharmaceutical reached a research collaboration deal with BioSurfaces to develop medical devices for the treatment of ...Learn More
Senseonics partners with Roche, TypeZero on automated insulin delivery system
A partnership has been reached by Senseonics, Roche Diabetes Care and TypeZero Technologies to create an automated insulin ...Learn More
FDA clears Vertera Spine's lumbar interbody fusion device
The FDA has given Vertera Spine clearance to market its COALESCE porous PEEK Lumbar Interbody Fusion Device for use in ...Learn More
I would like to be known as a person who is concerned about freedom and equality and justice and prosperity for all people.
...Rosa Parks, civil rights activist
Funding round pulls in $30M for Exosome Diagnostics
A round of Series C financing led by Tiger Partners and Forbion Capital Partners pulled in $30 million for Exosome ...Learn More
BioSig Technologies obtains $1.6M in funding round
A round of equity and options financing involving 22 unnamed investors pulled in $1.6 million for BioSig Technologies, an ...Learn More
Vixiar Medical gets $1.5M-plus boost
A round of seed financing brought in more than $1.5 million for Annapolis, Md.-based Vixiar Medical, which makes noninvasive ...Learn More
Financing round brings in $8M for Hinge Health
A round of Series A financing pulled in $8 million for Hinge Health, a startup that offers a kit of hardware and software ...Learn More
Global heart valve repair, replacement devices market poised for growth
The worldwide heart valve repair and replacement devices market is expected to see a 10.9% compound annual growth rate ...Learn More
Report predicts expansion of global bone growth stimulator market
A Research and Markets report predicts the worldwide market for bone growth stimulators will reach $3.9 billion by 2025 with ...Learn More
This wearable measures your emotions
Forget the mood rings. ...Learn More
Study examines demographic-specific data inclusion in device trials
A study of 82 trials supporting FDA premarket approval of medical devices in 2015 showed 4% of the studies evaluated product ...Learn More
ASCO guidelines recommend Agendia's MammaPrint test
Updated American Society of Clinical Oncology guidelines indicate that Agendia's MammaPrint 70-gene lab test can guide ...Learn More
EU approves Masimo's RPVi device
Masimo's RPVi device has been granted CE mark approval by European regulators. ...Learn More
AdvaMed raises concerns about final rule on "intended uses"
The FDA should scrap the "totality of the evidence" standard in the final tobacco product classification rule's definition ...Learn More
You are not here merely to make a living. You are here in order to enable the world to live more amply, with greater vision, with a finer spirit of hope and achievement. You are here to enrich the world, and you impoverish yourself if you forget the...
...Woodrow Wilson, 28th US president
Alere subsidiary to be acquired by Siemens Healthineers
Siemens Healthineers has agreed to pay an undisclosed amount for Alere's point-of-care blood diagnostics subsidiary, Epocal. ...Learn More
Tissue Regenix reaches $30M deal to buy CellRight Technologies
UK-based regenerative medicine firm Tissue Regenix reached a deal to acquire its San Antonio-based competitor CellRight ...Learn More
Titan Medical raises additional $1.3M in offering
The second tranche of Titan Medical's public offering of shares has pulled in $1.3 million, bringing the offering's total ...Learn More
Offering pulls in $6M for NxThera
An offering of convertible promissory notes and Series C preferred stock warrants brought in an additional $6 million for ...Learn More
Fla. medtech company gets $6.6M boost
A round of financing pulled in $6.6 million for Winter Park, Fla.-based Genicon, which makes devices for laparoscopic ...Learn More
Trial begins for Pops! Diabetes Care's glucose testing device
Pops! Diabetes Care said the first patient in a trial of its Pops! ...Learn More
WHO prequalifies HIV test from OraSure
The World Health Organization granted OraSure Technologies prequalification for its OraQuick HIV Self-Test, a product that ...Learn More
AdvaMed comments on Medicare coverage for ICDs
Comments have been submitted by AdvaMed and other stakeholders about the CMS' national coverage analysis for implantable ...Learn More
Draft guidance on medtech safety, performance requirements issued by India
A draft guidance was released by the Indian government under its impending Medical Devices Rules, set to take effect next ...Learn More
Recall of Penumbra's revascularization device labeled Class I by FDA
A recall initiated by Penumbra involving 155 units of its Penumbra 3D Revascularization device, designed for acute ischemic ...Learn More
Without passion man is a mere latent force and possibility, like the flint which awaits the shock of the iron before it can give forth its spark.
...Henri-Frederic Amiel, philosopher
AdvaMed, others will seek new opportunities to repeal ACA taxes
If Republican efforts to repeal or replace the Affordable Care Act fail, health care industry groups will look to attach ...Learn More
Abbott CEO bullish on Alere purchase completion this year
Abbott Laboratories CEO Miles White said Thursday in an earnings call that he was "quite confident" the company will ...Learn More
ConvaTec enters $120.5M deal to acquire Woodbury Holdings
ConvaTec has reached an agreement with MTS Health Investors to pay about $120.5 million for Woodbury Holdings, an ...Learn More
Funding round pulls in $35.5M for Amphora Medical
A round of Series B financing led by Boston Scientific and Longitude Capital brought in $35.5 million for Maple Grove, ...Learn More
Offering could bring in $31M for Apollo Endosurgery
A public offering of 5.7 million shares of common stock has been priced by Apollo Endosurgery in hopes of obtaining about ...Learn More
Chinese surgical navigation device developer gets $17M boost
A round of Series A financing led by Chinese health care-focused investment fund Huayi Capital pulled in $17 million for ...Learn More
First procedures using MRIdian Linac system recorded by ViewRay
Patients at the Henry Ford Health System in Detroit were the first to undergo treatment procedures using the MRIdian Linac ...Learn More
CDRH unveils changes to process for consensus standard recognition requests
The FDA's Center for Devices and Radiological Health provided clarification on how it will process requests for recognition ...Learn More
Aspect Imaging's neonatal MRI system wins FDA clearance
Aspect Imaging obtained 510(k) clearance from the FDA for its Embrace Neonatal MRI System, a device that facilitates imaging ...Learn More
Canada OKs Cardiac Science's automated external defibrillator
The Powerheart G5 automated external defibrillator from Cardiac Science has been granted approval by Health Canada. ...Learn More
Nothing great in the world has been accomplished without passion.
...Georg Wilhelm Friedrich Hegel, philosopher
Senior notes offering could pull in $3B for Thermo Fisher Scientific
An offering of floating rate senior notes due 2019, 1.4% senior notes due 2026, 1.95% senior notes due 2029 and 2.875% ...Learn More
Simplify Medical obtains $21M in funding round
A round of Series B financing led by Life Sciences Partners has brought in $21 million for Simplify Medical. ...Learn More
Public offering brings in $10M for OpGen
A public offering of common stock and stock purchase warrants has pulled in $10 million for Gaithersburg, Md.-based OpGen. ...Learn More
Private placement pulls in $9M for 4C Medical Technologies
Brooklyn Park, Minn.-based 4C Medical Technologies has raised about $9 million in gross proceeds in a private placement of ...Learn More
BioAffinity secures $4M-plus in financing round
A round of Series A financing has pulled in over $4 million for San Antonio-based bioAffinity Technologies, maker of the ...Learn More
Report predicts growth for N. American spinal implants market
A Data Bridge Market Research report predicts the North American market for spinal implants will hit $7 billion by 2024 with ...Learn More
Data show positive results for Fortimedix's single-port surgical system
Data from studies presented at the annual International Congress of the European Association for Endoscopic Surgery showed ...Learn More
Biotronik launches Intica line of ICDs
Biotronik's Intica DX and Intica cardiac resynchronization therapy-DX implantable cardioverter defibrillators have been ...Learn More
AliveCor teams up with Mayo Clinic on long QT syndrome screening
AliveCor will integrate its artificial intelligence technology with the Mayo Clinic's patented algorithms under a ...Learn More
BD's flow cytometer system wins FDA clearance
The FDA granted Becton Dickinson 510(k) clearance for its BD FACSLyric flow cytometer system, which is designed to be used ...Learn More
No one is completely unhappy at the failure of his best friend.
...Groucho Marx, comedian
German imaging software company acquired by Royal Philips
Royal Philips has paid an undisclosed amount for TomTec Imaging Systems, a German imaging software company that provides ...Learn More
Funding round pulls in $47M for Silk Road Medical
A round of funding led by Norwest Venture Partners and Janus Capital Management funds has brought in $47 million for ...Learn More
Cogentix, Promepla enter exclusive license deal
An exclusive license agreement has been reached by Cogentix Medical and Monaco-based Promepla to release an endourology ...Learn More
J&J sees highest Q2 sales growth in medical device business
Johnson & Johnson's medical device business saw a 4.9% year-over-year increase in sales during the second quarter, ...Learn More
Report predicts growth for spine biologics market
A Market Research Engine report predicts the worldwide spine biologics market will reach over $2.5 billion by 2022 at a 4.4% ...Learn More
Trial of Intact Vascular's endovascular system launched in Europe
The first European patient in a study of Intact Vascular's Tack endovascular system, designed for arterial dissection ...Learn More
ElectroCore launches episodic cluster headache treatment device
The gammaCore was launched by ElectroCore for use in acute treatment of episodic cluster headache in adults. ...Learn More
FDA expands use of Thermo Fisher's BRAHMS PCT assay
The FDA has given Thermo Fisher Scientific business BRAHMS 510(k) clearance for expanded use of its procalcitonin-sensitive ...Learn More
Emerging Implant Technologies' 3D-printed cage portfolio OK'd by FDA
The full 3D-printed cage portfolio of Emerging Implant Technologies has received clearance from the FDA. ...Learn More
EU OKs bacterial panel from T2 Biosystems
T2 Biosystems' T2Bacteria Panel has been granted CE mark approval by European regulators. ...Learn More
There is no end. There is no beginning. There is only the infinite passion of life.
...Federico Fellini, film director
Alere's Triage assets to be acquired by Quidel in $440M deal
Quidel has agreed to pay $400 million plus $40 million in contingent consideration for Alere's Triage MeterPro ...Learn More
Funding round brings in $11.2M for Claret Medical
A round of equity financing involving 34 anonymous sources has pulled in $11.2 million for Santa Rosa, Calif.-based Claret ...Learn More
Rapid Medical obtains $9M in funding round
A round of Series B financing brought in $9 million for Rapid Medical, an Israeli developer of neurovascular interventional ...Learn More
Funding round pulls in $6.3M for OrthoSensor
An offering of debt, warrants, options and securities involving 15 unnamed investors brought in $6.3 million for ...Learn More
Wash. medtech startup gets $5M boost
Redmond, Wash.-based VerAvanti has raised $5 million in a round of funding to support its development of products for stroke ...Learn More
Tender offer for Alere shares initiated by Abbott
A tender offer for all outstanding shares of Alere's Series B convertible perpetual preferred stock has been launched by ...Learn More
Medtronic's quarterly revenue to hit lower end of forecast, exec says
Medtronic's fiscal first-quarter revenue growth will fall within the lower end of its forecast because of a weeklong ...Learn More
Who could replace Zimmer Biomet's CEO?
Zimmer Biomet recently surprised with the announcement that CEO David Dvorak is immediately stepping down. ...Learn More
Data show positive results for Medtronic's InterStim device
Five-year data from a 340-patient study in the Journal of Urology showed that the use of Medtronic's InterStim ...Learn More
Researchers develop diagnostic device for blood-based tumor cells detection
A mobile diagnostic device was created and patented by a team of researchers from Spain's Rovira i Virgili University to ...Learn More
UK allots $112.1M for health care technologies
A total of approximately $112.1 million in funding for small and midsize developers of medical devices, digital health ...Learn More
A good plan is a simple plan.
...Jim Rohn, entrepreneur and motivational speaker
$81M deal to buy Spirox finalized by Entellus Medical
The acquisition of Spirox, maker of the Latera absorbable nasal implant, has been completed by Entellus Medical in a ...Learn More
Sensome obtains about $5.4M in seed funding round
A round of seed financing led by Kurma Diagnostics pulled in approximately $5.4 million for Sensome, a French company that ...Learn More
Funding boost secured by cataract treatment device maker
A round of venture capital funding involving the Global Health Investment Fund and Visionary Venture Fund has brought in an ...Learn More
Sphere Medical looks to raise working capital
Sphere Medical, maker of the Proxima medical monitoring system, said it is weighing its "immediate financing options" to ...Learn More
Abbott reaches diabetes-management partnership with Bigfoot Biomedical
A partnership has been reached by Abbott Laboratories and Bigfoot Biomedical to integrate Bigfoot's insulin delivery ...Learn More
Report predicts growth for global pedicle screw systems market
A Future Market Insights report predicts the worldwide market for pedicle screw systems will see growth because of an aging ...Learn More
3D-printed artificial heart created by scientists
Researchers from Switzerland's ETH Zurich have used 3D printing to develop an artificial heart out of silicone to mimic the ...Learn More
$1M grant to support Feinstein Institute's electronic pancreas
The Knapp Family Foundation awarded the Feinstein Institute for Medical Research a $1 million grant to explore biolectronic ...Learn More
Limited release of expandable interbody system announced by SeaSpine
The Skipjack Expandable Interbody System was launched on a limited basis by SeaSpine. ...Learn More
Australia, Singapore approve assays from Vela Diagnostics
The Australian Therapeutic Goods Administration has given Vela Diagnostics approval for its Sentosa SQ HIV genotyping assay, ...Learn More
You are what you do. If you do boring, stupid, monotonous work, chances are you'll end up boring, stupid, and monotonous.
...Bob Black, writer
BioTelemetry announces completion of $280M LifeWatch acquisition
The acquisition of remote cardiac monitoring company LifeWatch has been completed by BioTelemetry in a cash-and-stock deal ...Learn More
Finnish genetic diagnostics firm obtains $16M in funding round
A round of funding has pulled in about $16 million for Finland-based Blueprint Genetics, a company that makes genetic tests ...Learn More
Public offering could bring in $10M for OpGen
A public offering of common stock and common warrants has been priced by OpGen in hopes of raising $10 million. ...Learn More
Funding round pulls in $3.1M for early-stage wound care company
A financing round has brought in $3.1 million for Gel-e, an early-stage wound care company based in College Park, Md. ...Learn More
New vice president, chief commercial officer named by Vertiflex
Michael Enxing, former vice president of sales at Nevro, has been tapped to serve as vice president and chief commercial ...Learn More
First commercial use of Tag thoracic stent graft recorded by W.L. Gore
A patient at St. Franziskus Hospital in Germany was the first to undergo a procedure using W.L. ...Learn More
Royal Philips' wearable light therapy device wins FDA clearance
Royal Philips has obtained 510(k) clearance from the FDA for its BlueControl wearable light therapy device, a technology ...Learn More
Integrated diabetes management app debuted by Novo Nordisk, Glooko
The Cornerstones4Care App has been launched by Novo Nordisk and Glooko for use in diabetes management. ...Learn More
House subpanel weighs bills on medical product communication
The House Energy and Commerce Health Subcommittee held a hearing on draft bills that would provide clarification on the ...Learn More
FDA clears Tyber Medical's extremity joint fixation system
Tyber Medical's TyFix All-in-One Extremity Joint Fixation system has been granted 510(k) clearance by the FDA. ...Learn More
I am tomorrow, or some future day, what I establish today. I am today what I established yesterday -- or some previous day.
...Harvey Spencer Lewis, writer
IPO brings in $7.1M for Co-Diagnostics
An initial public offering of over 1.1 million shares on the Nasdaq Capital Market pulled in $7.1 million in gross proceeds ...Learn More
Beaver-Visitec announces acquisition of Dutch ophthalmic tech firm
Dutch ophthalmic device maker Vitreq has been acquired by Waltham, Mass.-based Beaver-Visitec for undisclosed terms. ...Learn More
Private placement pulls in $7M for NeuroMetrix
A private placement of Series F convertible preferred stock has brought in about $7 million in gross proceeds for ...Learn More
Premaitha Health secures $5M loan facility from Thermo Fisher
Thermo Fisher Scientific has agreed to provide Premaitha Health a secured loan facility worth $5 million, of which $4 ...Learn More
Dvorak resigns as Zimmer Biomet CEO, president
David Dvorak has resigned as president, CEO and board member of Zimmer Biomet but will stay with the company in an advisory ...Learn More
Uromedica's continence therapy system wins CMS reimbursement
The CMS has issued a reimbursement code to Uromedica for its ProACT Adjustable Continence Therapy for Men, a system ...Learn More
New site added by InVivo for neurospinal scaffold trial
Stanford Medicine has been added by InVivo Therapeutics as a clinical site for the study of its Neuro-Spinal Scaffold, ...Learn More
GE enters licensing deal on asymptomatic malaria detection
GE, the Global Good Fund and Access Bio will make and distribute rapid diagnostic technologies for asymptomatic malaria ...Learn More
User fee reauthorization bill clears House
A bill that would reauthorize the FDA's user fee agreements for medical devices, prescription and generic drugs and ...Learn More
Z-Medica's hemostatic dressing wins FDA clearance
The FDA has given Z-Medica clearance for its QuikClot Control+ nonabsorbable hemostatic dressing under the agency's de novo ...Learn More
MedTech Compliance 101: Boot Camp
Oct. ...Learn More
Most of the change we think we see in life is due to truths being in and out of favor.
...Robert Frost, poet
Boston Scientific promotes Watchman device in TV ad
Boston Scientific is running a television ad in Tampa, Fla., San Diego, Detroit and Phoenix to promote its Watchman device ...Learn More
Penumbra announces acquisition of Italian distributor
All of the outstanding shares of Crossmed, Penumbra's exclusive distributor in Italy, have been acquired by the Alameda, ...Learn More
Funding round pulls in $27M for Allurion Technologies
A round of Series C financing brought in $27 million for Natick, Mass.-based Allurion Technologies, which makes the Elipse ...Learn More
Innovative Cardiovascular Solutions gets $5M boost
An oversubscribed Series B financing round has pulled in $5 million for Kalamazoo, Mich.-based Innovative Cardiovascular ...Learn More
K2M, Mitsubishi unit reach long-term exclusive distribution deal
A deal has been reached by K2M with Mitsubishi subsidiary Japan Medicalnext to exclusively distribute K2M's spinal ...Learn More
New president, chief operating officer named by Spinal Elements
Jason Blain, who has more than 20 years of experience in the orthopedic industry, has been tapped to serve as president and ...Learn More
First UK site added by InVivo Therapeutics for neurospinal scaffold trial
James Cook University Hospital has been added by InVivo Therapeutics as the first UK clinical site for the trial of its ...Learn More
Study begins for Medtronic's Arctic Front Advance cryoballoon
The first patient in a prospective, randomized, controlled trial of Medtronic's Arctic Front Advance cryoballoon has been ...Learn More
FDA clears ECG analysis system from Cardiologs Technologies
Cardiologs Technologies has obtained 510(k) clearance from the FDA for its ECG Analysis Platform, a system that provides ...Learn More
FDA clears Stryker's radiofrequency energy generator
The FDA has granted Stryker 510(k) clearance for its MultiGen 2 radiofrequency energy generator, a device intended for use ...Learn More
Change doth unknit the tranquil strength of men.
...Matthew Arnold, poet
Private placement pulls in $5M for PAVmed
A private placement of senior notes and Series S warrants involving Scopia Holdings has brought in $5 million for New ...Learn More
Amendia to become Spinal Elements
Marietta, Ga.-based Amendia is adopting the name of the company it recently acquired, Spinal Elements, this year to reflect ...Learn More
Report predicts growth for global orthopedic trauma devices market
A Persistence Market Research report predicts the worldwide market for orthopedic trauma devices will hit $9.4 billion by ...Learn More
New chief medical officer named by InVivo Therapeutics
Richard Toselli, former chief medical officer at Cochlear, has been tapped to serve as chief medical officer of InVivo ...Learn More
Could dogs be better than medical devices at detecting cancer?
Dogs in the small Japanese town of Kaneyama are being trained to detect stomach cancer through their scent to try to combat ...Learn More
Study shows steady drop in US inferior vena cava filter usage
The use of inferior vena cava filters in the US dropped from 55.1 per 100,000 people in 2010 to 39.1 per 100,000 in 2014 due ...Learn More
Dexcom agrees to add Ascensia's BGMS to G5 Medicare offering
Ascensia Diabetes Care's Ascensia Contour Next One blood glucose monitoring system will be included in Dexcom's G5 CGM ...Learn More
Intact Vascular secures FDA approval to modify balloon angioplasty trial
The FDA has given Intact Vascular a supplemental investigational device exemption to change the 12-month primary endpoint in ...Learn More
EU OKs noninvasive fingertip sensor from Masimo
European regulators have given Masimo approval for its rainbow Super DCI-mini sensor, which is designed for the simultaneous ...Learn More
List of Class II device types exempt from 510(k) requirements finalized by FDA
A final list of 1,003 Class II medical device types exempted from premarket notification requirements under the 21st Century ...Learn More
Use of Medtronic's CoreValve TAVR systems expanded by FDA
Medtronic has obtained an expanded indication from the FDA for its CoreValve transcatheter aortic-valve replacement systems ...Learn More
Never tell people how to do things. Tell them what to do, and they will surprise you with their ingenuity.
...George S. Patton, military leader
Spirox to be acquired by Entellus Medical in $81M deal
Entellus Medical has agreed to pay about 3.4 million in shares of its common stock, valued at approximately $56 million, and ...Learn More
$5.3B Abbott merger deal secures Alere shareholder approval
An amended merger agreement between Abbott Laboratories and Alere, valued at approximately $5.3 billion, has been approved ...Learn More
CathVision gets boost from VF Venture, Borean Innovation
Scandinavia-based VF Venture and Borean Innovation have provided early-stage medtech firm CathVision a "multimillion venture ...Learn More
Funding round pulls in $5M for Myocardial Solutions
A round of equity financing involving 37 anonymous investors brought in $5 million for Myocardial Solutions, a filing with ...Learn More
Study predicts growth for global artificial disc market
The worldwide artificial disc market is expected to reach $4.8 billion by 2025 with Zimmer Biomet, DePuy Synthes, Stryker, ...Learn More
Study shows positive results for St. Jude's Amplatzer device
A study presented at the European Association of Percutaneous Cardiovascular Interventions' annual congress showed ...Learn More
Medtronic announces Japanese launch of Resolute Onyx drug-eluting stent
Medtronic is launching its Resolute Onyx drug-eluting stent in Japan today. ...Learn More
FDA outlines proposal for computer-simulated testing of devices, drugs
The approval process for medical devices and drugs could incorporate computer modeling and virtual testing in an effort to ...Learn More
Congenital disease IgM assay from Bio-Rad gets FDA clearance
Bio-Rad Laboratories' BioPlex 2200 ToRC IgM Assay has been granted clearance by the FDA. ...Learn More
EU approves neurovascular system from Cerus
European regulators have given Cerus Endovascular CE mark approval for its Contour neurovascular system, a device intended ...Learn More
We always may be what we might have been.
...Adelaide Anne Procter, poet
Axonics Modulation Technologies gets $21M boost
The second tranche of a Series C financing round has brought in $20.5 million for Axonics Modulation Technologies, an ...Learn More
SpineGuard implements profitability plan, names new CEO
SpineGuard has announced the implementation of its profitability plan to achieve a break-even point by 2018, which includes ...Learn More
Dune Medical Devices obtains $12.3M in funding round
A round of financing has brought in $12.3 million for Dune Medical Devices, which offers a radiofrequency spectroscopy ...Learn More
Offering brings in $2M for Delcath Systems
An offering of 2,360 shares of Series B preferred stock has pulled in $2 million for Delcath Systems, a company that is ...Learn More
Pentax Medical creates endoscopy joint venture with Chinese firm
A joint venture has been formed by Hoya Group's Pentax Medical division, based in Japan, and Chinese company Shanghai Aohua ...Learn More
GE Healthcare, HeartFlow reach systems integration deal
A collaborative agreement has been reached by GE Healthcare and HeartFlow to allow integration of the latter's FFRct ...Learn More
Trial evaluates IDx's automated screening solution for diabetic retinopathy
A clinical trial is being conducted by early-stage medtech firm IDx to secure FDA clearance for its IDx-DR, an automated ...Learn More
Medacta's Anterior Hybrid Interbody Fusion Device wins FDA clearance
Medacta International's MectaLIF Anterior Hybrid Interbody Fusion Device has been granted clearance by the FDA. ...Learn More
FDA, EU clear K2M's proximal fixation spinal system
The FDA has granted K2M clearance for its NILE Proximal Fixation Spinal System, a device intended for use in proximal ...Learn More
Beckman Coulter secures FDA clearance for blood cancer diagnostics
Beckman Coulter has obtained clearance under the FDA's de novo pathway to market its ClearLLab Reagents. ...Learn More
If you want to be a writer, write a little bit every day. Pay attention to the world around you. Stories are hiding, waiting everywhere. You just have to open your eyes and your heart.
...Kate DiCamillo, writer
ConforMIS obtains $15M in 2nd tranche of loan from Oxford Finance
The second tranche of a term loan with Oxford Finance has brought in $15 million for Billerica, Mass.-based ConforMIS, which ...Learn More
DOD taps Digirad for $100M CT imaging equipment devices contract
The Department of Defense's Defense Logistics Agency has awarded Suwanee, Ga.-based Digirad a potential 10-year, $100 ...Learn More
MedShape's ExoShape ACL system acquired by CONMED
The ExoShape ACL Fixation System has been acquired by CONMED under a definitive agreement with MedShape. ...Learn More
Respicardia gets $5.1M boost
A private debt placement involving 13 investors has pulled in $5.1 million for Respicardia, bringing the company closer to ...Learn More
Funding round pulls in $4.3M for Outset Medical
A round of mixed financing involving a single investor has brought in $4.3 million for San Jose, Calif.-based Outset ...Learn More
Report predicts growth for global spinal implants market
A Market Research Future report predicts the worldwide market for spinal implants will reach $14 billion by 2022 due to an ...Learn More
Medtronic's Micra pacemaker meets expectations in space test
A project conducted as part of the NASA-backed private education program Cubes in Space launched Medtronic's nano-sized ...Learn More
Additions to OSSEO-LOC product family fully released by Life Spine
The ProLift Expandable PLIF/TLIF Spacer System and TiBOW Expandable TLIF Spacer System have been fully launched by Life ...Learn More
FDA approves Edwards Lifesciences' bioprosthetic heart valve
Edwards Lifesciences has obtained approval from the FDA for its Inspiris Resilia bioprosthetic heart valve, a surgical ...Learn More
EU OKs Roche's MRSA/SA test on Liat PCR system
European regulators have given Roche CE-IVD marking for its Cobas methicillin-resistant Staphylococcus aureus and ...Learn More
Most people have to get to a point where they don't have a choice before they'll change something.
...Alex Marwood, writer
Exchange offers for Bard notes extended again by BD
Exchange offers for up to $1.1 billion worth of outstanding C.R. ...Learn More
Funding round brings in around $17.3M for UK medtech company
UK-based Creavo Medical Technologies has raised approximately $17.3M in a funding round involving investors from the US, ...Learn More
BioVentrix obtains $15M in offering
An offering of equity and convertible notes involving 152 unidentified investors has pulled in $14.5 million for BioVentrix, ...Learn More
Funding round pulls in $6.85M for Israeli device maker
A round of financing led by the OrbiMed Advisors venture capital fund has brought in $6.85 million for MobileODT, an Israeli ...Learn More
Theranica Bio-electronics gets $6M boost
A round of Series A financing has pulled in $6 million for Israel-based Theranica Bio-electronics, a medtech company that ...Learn More
CMS expands reimbursement coverage for Second Sight's Argus II system
The CMS has given expanded reimbursement coverage for Second Sight Medical's Argus II retinal prosthesis system, authorizing ...Learn More
Smith & Nephew teams up with UK university on advanced wound care
Smith & Nephew and the UK's University of Hull have reached a five-year partnership, valued at around $3.9 million, to ...Learn More
Researchers create 3D-printed heart valve models to improve TAVR outcomes
A study in JACC: Cardiovascular Imaging showed 3D-printed models that mimic heart valve tissue could lower the risk of ...Learn More
Stryker unit to debut deformity correction hardware, online app
The Hoffman LRF Hexapod hardware and online application is expected to be launched by Stryker's Foot and Ankle business unit ...Learn More
Canada OKs glucose monitoring system from Abbott
Health Canada has given Abbott a license for its FreeStyle Libre Flash Glucose Monitoring System for use in adults with ...Learn More
You manage things; you lead people.
...Grace Hopper, computer scientist and naval officer
Royal Philips acquires CardioProlific, divests Sonalleve MR-HIFU business
Royal Philips has paid an undisclosed amount for CardioProlific, a US-based company that makes catheter-based thrombectomy ...Learn More
Austrian diabetes app company acquired by Roche
Roche has announced its acquisition of Vienna-based diabetes-management platform mySugr as part of an effort to expand its ...Learn More
Report predicts growth for global sports medicine market
A Market Data Forecast report predicts the worldwide sports medicine market will hit $8.4 billion by 2021 at an 8.1% ...Learn More
HP's new 3D printers: Here's why Proto Labs likes them
Quick-turn manufacturer Proto Labs is among a number of companies testing the new HP Multi Jet Fusion technology for ...Learn More
Trial shows Bio2's catheter-filter combo effective against pulmonary embolism
A 163-patient pivotal study showed use of Bio2 Medical's Angel combined IVC filter/central venous catheter in critically ill ...Learn More
ElectroCore eyes gammaCore's initial US release this month
ElectroCore will initially release its handheld gammaCore vagus-nerve stimulation device, which was cleared by the FDA in ...Learn More
Recommendations for metal-on-metal hip replacements updated by MHRA
Updated follow-up recommendations for metal-on-metal hip replacements have been released by the UK's Medicines and ...Learn More
FDA clears Varian's image-guided radiotherapy system
Varian's Halcyon image-guided volumetric intensity modulated radiotherapy system has been granted 510(k) clearance by the ...Learn More
MedTech Compliance 201: A Deeper Dive Into The Compliance Landscape
Oct. ...Learn More
SmartBrief will not publish Tuesday
...In observance of Independence Day in the US, SmartBrief will not publish Tuesday. Publication will resume Wednesday.
As long as our government is administered for the good of the people, and is regulated by their will; as long as it secures to us the rights of persons and of property, liberty of conscience and of the press, it will be worth defending.
...Andrew Jackson, seventh US president
Thermo Fisher to invest $9.5M in Va. expansion project
Thermo Fisher Scientific is expected to invest $9.5 million in the expansion of its clinical diagnostic operation in ...Learn More
OpGen looks to raise up to $15.6M in public offering
A previously announced public offering has been upsized by OpGen in hopes of raising up to $15.6 million, according to an ...Learn More
GeneNews gets $10M boost in financing agreement
A binding agreement has been reached by Canadian diagnostic firm GeneNews with multinational private equity firm Milost for ...Learn More
Public offering pulls in $5.6M for Titan Medical
A public offering of almost 48.4 million shares has brought in approximately $5.6 million in gross proceeds for ...Learn More
3 studies launched to assess CardioFocus' HeartLight ablation system
CardioFocus said three studies that will enroll a total of more than 1,000 participants have been initiated for assessing ...Learn More
DePuy Synthes announces US launch of 2 fenestrated screw systems
The Viper and Expedium Fenestrated Screw Systems have been launched by DePuy Synthes in the US for use with Confidence High ...Learn More
X-ray-based surgical planning system unveiled by Zimmer Biomet
The X-PSI Knee System, an X-ray-based surgical planning system for patient-specific implant positioning, has been introduced ...Learn More
SciBase's melanoma detection device wins FDA approval
SciBase obtained approval from the FDA for Nevisense, a device designed to facilitate detection of early stages of malignant ...Learn More
EU approves Hologic's Panther Fusion system, assays
European regulators have given Hologic CE mark approval for its Panther Fusion System, an in-lab upgrade to the automated ...Learn More
FDA OKs Illumina's Vectibix companion Dx on MiSeqDx system
The FDA has given Illumina approval for its Extended RAS Panel for use on its MiSeqDx system. ...Learn More
PMA Submissions Workshop
Oct. ...Learn More
Great thoughts, like great deeds, need no trumpet.
...Philip James Bailey, poet
Philips reaches $2.17B deal to acquire Spectranetics
Philips will pay approximately $2.17 billion, including debt, to acquire US cardiac device maker Spectranetics under an ...Learn More
At-the-market program for stock offering announced by Chembio
An at-the-market program has been established by Chembio Diagnostics through which it may occasionally offer up to $21.2 ...Learn More
Public offering could pull in $11.5M for Titan Medical
Titan Medical has announced plans to launch a public offering of as much as 100 million shares in hopes of raising up to ...Learn More
Intellirod Spine gets $1M-plus boost, new intellectual property
A round of equity financing led by the OhioHealth Innovation Development Fund and Queen City Angel First Fund V has brought ...Learn More
Cardinal Health reaches distribution deal with GenePOC
Canadian molecular diagnostics firm GenePOC and Cardinal Health have reached an agreement allowing Cardinal to exclusively ...Learn More
Study of InVivo's neuro-spinal scaffold reports improvement in 2 patients
Two patients in a study of InVivo Therapeutics' Neuro-Spinal Scaffold have shown improvement, transitioning from sensory ...Learn More
EU OKs Medtronic's deep-brain stimulation software
European regulators have granted Medtronic CE mark approval for its SureTune3 deep-brain stimulation software, which gives ...Learn More
India considers price caps for additional medical devices
Indian health authorities are considering adding such medical devices as orthopedic implants, heart valves, intraocular ...Learn More
K2M's 3D-printed corpectomy cage wins FDA clearance
K2M's 3D-printed corpectomy cage, Capri Small 3D Static Corpectomy System, has been granted clearance by the FDA. ...Learn More
Quidel secures FDA clearance, CLIA waiver for RSV assay on analyzer
The FDA has given Quidel clearance for its Sofia RSV Fluorescent Immunoassay for use on the Sofia 2 Fluorescent Immunoassay ...Learn More
IDE Submissions Workshop
Oct. 18 | Washington, D.C. ...Learn More
Just remember, you can do anything you set your mind to, but it takes action, perseverance and facing your fears.
...Gillian Anderson, actress
DePuy Synthes announces acquisition of Sentio
Innovative Surgical Solutions, a Wixom, Mich.-based spinal nerve localization technology developer that operates as Sentio, ...Learn More
Strategy to maintain growth unveiled by Boston Scientific
Boston Scientific said it plans to expand into "high-growth adjacent markets" and minimize its footprint in low-growth ...Learn More
Financing round brings in $35M for Glooko
A round of Series C financing involving Medtronic, Insulet, the Mayo Clinic, Samsung NEXT and other investors has pulled in ...Learn More
Gates Foundation, OraSure to bring HIV test to developing nations
A deal has been reached by OraSure Technologies and the Bill & Melinda Gates Foundation to provide 50 developing Asian and ...Learn More
Funding round pulls in $1M for Aortica
A round of mixed financing involving 11 unnamed investors brought in $1 million for Aortica, an SEC filing showed. ...Learn More
Trial advances for InVivo Therapeutics' neurospinal scaffold
The 17th patient in a trial of the Neuro-Spinal Scaffold has been enrolled by InVivo Therapeutics. ...Learn More
FDA clears Royal Philips' IntelliSpace Portal 9.0
The FDA has granted Royal Philips 510(k) clearance for the ninth version of the IntelliSpace Portal image analytics ...Learn More
Biologics line debuted by ChoiceSpine
ChoiceSpine announced the launch of its biologics portfolio, which includes the STRATOFUSE line of allograft and synthetic ...Learn More
Abbott's molecular CMV test wins FDA approval
The FDA has given Abbott approval for its RealTime CMV molecular test, a PCR-based assay designed to facilitate the ...Learn More
Spineology's lumbar interbody fusion system cleared by FDA
Spineology obtained clearance from the FDA to market its Rampart One Anterior Lumbar Interbody Fusion System, an implant ...Learn More
Trump Administration Trade and Tax Policies: Impact to Supply Chain and Business Operations
July 20 | WebinarPharmaceutical and life sciences companies are facing a wave of change that could affect their businesses, ...Learn More
Coming up with an idea is the least important part of creating something great. ... The execution and delivery are what's key.
...Sergey Brin, computer scientist and entrepreneur
AdvaMed asks Supreme Court to review lower-court decision in Ethicon case
An amicus curiae brief has been filed by AdvaMed with the Supreme Court to request review of a lower-court decision in a ...Learn More
For more:
...Learn more about the amicus brief filed by AdvaMed with the US Supreme Court in the Ethicon v. Huskey case.
Halt Medical buyout, first tranche of $30M funding round closed by Acessa
Acessa Health announced completion of its bankruptcy buyout of Halt Medical, which includes Halt's Acessa radiofrequency ...Learn More
NanoVibronix looks to obtain up to $10M in funding round
A prospectus has been filed by NanoVibronix in hopes of raising up to $10 million in a round of financing. ...Learn More
Funding round pulls in $3.5M for eLum Technologies
A round of Series A financing has brought in $3.5 million for eLum Technologies, an early-stage medtech company based in ...Learn More
New CEO named by Conventus Orthopaedics
Matthew Jewett has been tapped to serve as CEO of Conventus Orthopaedics. ...Learn More
Two Supreme Court decisions take a whack at patent holders
Recent Supreme Court decisions dealing with patents have some experts concerned about a weakening of patent holders' rights. ...Learn More
Medtronic, Aetna enter outcomes-based agreement for insulin pumps
Medtronic and health insurer Aetna have agreed to use clinical outcomes as the basis of payment for Medtronic's insulin pump ...Learn More
Premera Blue Cross to cover use of Interpace's thyroid test
Interpace Diagnostics' ThyraMIR test has obtained a positive coverage policy decision from Premera Blue Cross as a test for ...Learn More
FDA clears Merit Medical's Embosphere Microspheres
The FDA has given Merit Medical Systems de novo clearance for its Embosphere Microspheres for treating symptomatic enlarged ...Learn More
Summit Medical's jaw fracture recovery device cleared by FDA
The FDA has granted Summit Medical clearance to market its noninvasive jaw fracture recovery device, which evenly fixes the ...Learn More
EU OKs Channel Medsystems' endometrial ablation device
The Cerene cryotherapy endometrial ablation device from Emeryville, Calif.-based Channel Medsystems has been granted CE mark ...Learn More
510(k) Submissions Workshop
Oct. 16-17 | Washington, D.C.FDA and industry experts are coming together to teach you the basics of 510(k) submissions. ...Learn More
Criticism is so often nothing more than the eye garrulously denouncing the shape of the peephole that gives access to hidden treasure.
...Djuna Barnes, writer and artist
$5B share buyback program OK'd by Medtronic's board
A plan by Medtronic to buy back $5 billion of company stock in a new program superseding a 2015 share repurchasing plan has ...Learn More
Dallas health care investment firm gets boost for $30M follow-on fund
Dallas-based Green Park & Golf Ventures has brought in a third of its $30 million target for a follow-on investment fund, ...Learn More
Report predicts growth for global orthopedic devices market
A Market Data Forecast report predicts the worldwide market for orthopedic devices will reach $49.14 billion by 2021 with a ...Learn More
US surgical navigation systems, robotics systems markets poised for growth
An iData Research report predicts the US market for surgical navigation systems will hit $132.7 million by 2023 and will ...Learn More
Acelity appoints new execs
Ramesh Subrahmanian, former international group president for Stryker, has been appointed as president of the international ...Learn More
First procedure using Speedboat device recorded by Creo Medical
A patient at St. ...Learn More
Roche's HIV assay wins FDA approval
The Elecsys HIV combi PT assay, Roche Holding's fourth-generation HIV combination antigen-antibody assay, has been granted ...Learn More
FDA labels recall of Teleflex unit's catheters as Class I
A recall initiated by Teleflex covering 4,679 units of Venture surgical catheters, manufactured by its subsidiary Vascular ...Learn More
C.R. Bard's covered iliac stent gets premarket approval from FDA
The FDA has given C.R. ...Learn More
EU OKs RHD genotyping test from Grifols
European regulators have given Grifols CE mark approval for its ID RHD XT diagnostic test for RHD genotyping. ...Learn More
I can't give you a surefire formula for success, but I can give you a formula for failure: Try to please everybody all the time.
...Herbert Bayard Swope, journalist
Swedish IPO pulls in $57.4M for Bonesupport
An initial public offering of more than 17.2 million shares on the Swedish stock exchange, Nasdaq Stockholm, has brought in ...Learn More
Placement pulls in about $4.9M for Oventus Medical
A private placement has brought in approximately $4.9 million for Oventus Medical, an Australian company that makes oral ...Learn More
Great Basin Scientific gets $2.1M boost
An offering of 8.9 million units of common stock, warrants and stock purchase warrants has pulled in $2.1 million in net ...Learn More
Report predicts growth for global minimally invasive surgery market
A Zion Market Research report predicts the worldwide minimally invasive surgery market will see growth through 2024 because ...Learn More
US patent issued for Zyga's SImmetry Decorticator
The US Patent and Trademark Office has issued a new patent for Zyga Technologies' SImmetry Decorticator, an instrument that ...Learn More
Exactech's shoulder, knee and hip replacement systems win approval in Japan
Japanese regulators have given Exactech approval for its shoulder, knee and hip replacement systems, including the Novation ...Learn More
Single-use kit of tools for wrist fracture surgery debuted by DePuy Synthes
The Distal Radius Sterile Kit has been launched by DePuy Synthes for use in surgical treatment of wrist fractures. ...Learn More
Medical device tax repeal included in Senate GOP's ACA replacement bill
Senate Republicans released the Better Care Reconciliation Act, a bill aimed at repealing provisions of the Affordable Care ...Learn More
FDA, EU clear Implanet's redesigned JAZZ braid
The FDA has given Implanet clearance to market the improved version of its JAZZ braid, part of which is now ultrasonically ...Learn More
ClearFlow's active clearance technology system wins FDA clearance
The FDA has granted Anaheim, Calif.-based ClearFlow 510(k) clearance for its FlowGlide active clearance technology system, a ...Learn More
Anyone can hold the helm when the sea is calm.
...Publilius Syrus, writer
Philips enters $36.7M deal to acquire Electrical Geodesics
Philips has agreed to pay $36.7 million for Oregon-based medical device firm Electrical Geodesics in a deal that represents ...Learn More
Public offering brings in $12.2M for Interpace Diagnostics
Interpace Diagnostics has obtained $12.2 million in net proceeds from its public offering of 9.9 million shares of common ...Learn More
410 Medical gets $2.1M funding boost
A round of Series A financing has pulled in an additional $2.1 million for Durham, N.C.-based 410 Medical, raising the ...Learn More
Adaptive Biotechnologies enters Dx partnership with Janssen
Adaptive Biotechnologies and Johnson & Johnson subsidiary Janssen have agreed on a collaboration to assess the effectiveness ...Learn More
SpineGuard reaches distribution deal with XinRong Medical
SpineGuard and XinRong Medical Group have reached an agreement for the exclusive distribution of SpineGuard's PediGuard in ...Learn More
Study shows positive results for Glaukos' iStent plus topical travoprost
A 53-patient study showed that the use of Glaukos' iStent device in combination with topical travoprost for treating ...Learn More
ImpediMed's bioimpedance spectroscopy system gains EU approval
European regulators have given ImpediMed CE mark approval for its Sozo bioimpedance spectroscopy platform, which uses the ...Learn More
New 1.5T MR system unveiled by Toshiba Medical
The Vantage Titan/Zen Edition 1.5T has been launched by Toshiba Medical for speeding workflow and reducing patient ...Learn More
Trade office: India may face enforcement actions over medtech price controls
The Office of the US Trade Representative will attempt to resolve issues raised by US medtech companies about India's price ...Learn More
FDA expands MRI labeling for LivaNova's VNS Therapy device
LivaNova's Vagus Nerve Stimulation Therapy device has been granted expanded MRI labeling by the FDA. ...Learn More
Education ... is a process of living and not a preparation for future living.
...John Dewey, psychologist and educational reformer
Financing round brings in $34.6M for Reva Medical
A two-tranche round of financing has pulled in $34.6 million for San Diego-based Reva Medical, maker of the Fantom ...Learn More
Offering could pull in $947M for Danaher unit
An offering of senior notes has been priced by Danaher's wholly owned subsidiary, DH Europe Finance, in hopes of obtaining ...Learn More
Great Basin Scientific looks to raise $2.7M in offering
A public offering of securities has been priced by Great Basin Scientific in hopes of raising $2.7 million. ...Learn More
$6M 3D printing facility to be built in India for medical devices
A collaboration between 3D-printing platform think3D and medtech manufacturing park Andhra Pradesh MedTech Zone will build a ...Learn More
Infuseon enters glioblastoma treatment partnership with OncoSynergy
A strategic alliance has been reached by Infuseon Therapeutics and OncoSynergy to establish proof of concept for the direct ...Learn More
Report predicts growth for global sports medicine market
A Research and Markets report predicts the worldwide sports medicine market will see an 8.9% compound annual growth rate ...Learn More
Study advances for InVivo Therapeutics' neurospinal scaffold
The 16th patient in a study of the Neuro-Spinal Scaffold has been enrolled by InVivo Therapeutics at Allegheny General ...Learn More
Lordotic expandable interbody device unveiled by K2M
The SAHARA AL Expandable Stabilization System has been introduced by K2M for use in providing balance to the spine. ...Learn More
FDA clears inguinal hernia repairs with Intuitive Surgical's da Vinci Xi
The FDA has given Intuitive Surgical clearance for its da Vinci Xi robotic surgical system for use in inguinal hernia ...Learn More
ConforMIS' hip replacement system wins FDA clearance
The FDA granted ConforMIS 510(k) clearance for its iTotal Hip replacement system, which includes the company's iFit ...Learn More
FDA clears Hologic's HSV assay on Panther system
The FDA has given 510(k) clearance to Hologic for its Aptima Herpes Simplex Virus 1 & 2 molecular assay as part of its fully ...Learn More
Only someone who is well-prepared has the opportunity to improvise.
...Ingmar Bergman, director and screenwriter
Stryker enters $701M deal to buy Canadian imaging technology firm
Stryker will pay approximately $701 million for NOVADAQ Technologies, a Canadian maker of fluorescent imaging technology for ...Learn More
PerkinElmer announces $1.3B acquisition of German diagnostics firm
Massachusetts-based scientific instruments maker PerkinElmer reached a deal to acquire German medical diagnostics company ...Learn More
OpGen reaches supply agreement with Thermo Fisher
OpGen and Thermo Fisher Scientific have reached a supply agreement to commercialize OpGen's Acuitas Rapid Test for Pathogen ...Learn More
Mazor Robotics announces leadership changes
Mazor Robotics appointed Oren Zarchin to lead its newly created Product Development Group and Eli Zehavi to head its newly ...Learn More
New CEO named by Clear Guide Medical
Bob Cathcart has been tapped to serve as CEO of Johns Hopkins spinout Clear Guide Medical. ...Learn More
Battery-free pacemaker successfully powers the heart
A wireless, battery-free pacemaker has shown success in powering the heart in pig models, according to researchers from Rice ...Learn More
Study shows positive results for tibial base of DePuy Synthes' Attune system
A 30-patient study by the Canadian Radiostereometric Analysis Network showed stable fixation in knee replacement with the ...Learn More
MDxHealth, QUT bluebox enter scientific deal on oral cancer test
A scientific agreement between MDxHealth and QUT bluebox, the Queensland University of Technology's commercialization arm, ...Learn More
FDA clears Meditech Spine's intervertebral body device
Meditech Spine obtained clearance from the FDA for its Talos Lumbar (HA) Peek IBF, an intervertebral body device for ...Learn More
CBO estimates costs of implementing user fee reauthorization bill
The FDA would require appropriations worth $1.2 billion from 2018 to 2022 to implement changes in the Senate's user fee ...Learn More
Mass. governor to propose $500M medtech, biotech initiative
Massachusetts Gov. ...Learn More
With ordinary talent and extraordinary perseverance, all things are attainable.
...Thomas Fowell Buxton, politician and abolitionist
Calif. neurological-focused device startup obtains $14M in funding round
A round of Series A financing has brought in $14 million for Mindstrong Health, a Palo Alto, Calif.-based startup focused on ...Learn More
Offering could pull in $13.7M for Interpace Diagnostics
A public offering of 12.5 million shares of common stock and warrants to buy up to 12.5 million additional shares has been ...Learn More
Funding round pulls in $10.2M for Tusker Medical
An equity offering involving an unnamed investor has brought in $10.2 million for Menlo Park, Calif.-based Tusker Medical, a ...Learn More
Convertible note offering brings in $5M for GI Dynamics
An offering of convertible notes involving the Crystal Amber Fund has pulled in $5 million for GI Dynamics. ...Learn More
Atomo Diagnostics gets $1.08M boost
Atomo Diagnostics has secured an additional $1.07 million from New York-based Global Health Investment Fund, property ...Learn More
Case presentation shows positive results for Neovasc's transcatheter device
A case presentation at the annual Transcatheter Valve Therapies conference showed positive outcomes from the use of ...Learn More
FDA OKs Bayer's Betaseron autoinjector, companion app
The FDA has given Bayer approval for the Betaconnect electronic autoinjector and its companion app, myBETAapp, for use in ...Learn More
US lawmakers call for reconsideration of India's cardiac stent price cap
A group of 18 US lawmakers sent a letter to India's ambassador to Washington asking the country to reconsider its price cap ...Learn More
Essential Diagnostics List to be developed by WHO
The World Health Organization is expected to develop an Essential Diagnostics List, using recommendations from an expert ...Learn More
EU expands approval for Agilent's Opdivo companion Dx
European regulators have given Agilent Technologies expanded CE mark approval for its Dako PD-L1 IHC 28-8 pharmDx test for ...Learn More
The optimist proclaims that we live in the best of all possible worlds, and the pessimist fears this is true.
...James Branch Cabell, writer
Accuray gets $52M boost in revolving loan agreement
A revolving loan agreement has been reached by Accuray with MidCap Financial Trust for a senior secured revolving loan ...Learn More
Healthquad raises $12M to invest in Indian health care companies
Health care-focused venture capital fund Healthquad secured a total commitment of approximately $12 million to use in ...Learn More
Canadian medtech company obtains $7.6M in funding round
A round of Series A venture capital financing has brought in approximately $7.6 million for Evasc Neurovascular Enterprises, ...Learn More
Funding round brings in $5.5M for Spry Health
A round of Series A funding pulled in $5.5 million for Palo Alto, Calif.-based remote patient monitoring solutions maker ...Learn More
Report predicts growth for global heart valve device market
A Transparency Market Research report predicts the worldwide market for heart valve devices will reach $14.4 billion in ...Learn More
Neb. science project to test Medtronic's Micra pacemaker in space
Medtronic's nano-sized Micra pacemaker will be launched into space next week to examine the effects of extremely low ...Learn More
Siemens Healthineers' 3-Tesla MRI scanner wins FDA clearance
The FDA has cleared the Magnetom Vida 3-Tesla MRI scanner from Siemens Healthineers. ...Learn More
Gottlieb announces pilot project for regulating digital health products
A soon-to-be-launched FDA pilot program would establish a third-party certification program allowing companies to market ...Learn More
EU OKs Abbott's Alinity hq hematology analyzer
European regulators have given Abbott Laboratories CE mark approval for its Alinity hq hematology analyzer, an instrument ...Learn More
Recall of catheter tip syringes issued by Becton Dickinson
A recall has been initiated by Becton Dickinson involving 275 lots of its 100ml Plastipak catheter tip syringes because of ...Learn More
Any clod can have the facts, but having opinions is an art.
...Charles McCabe, columnist
Upsized offering could bring in $75M for GenMark Diagnostics
A previously announced public offering has been upsized by GenMark Diagnostics to offer about 6.4 million shares of its ...Learn More
Funding round pulls in $4M for Saranas
A round of Series B financing has brought in $4 million for Houston-based Saranas, which makes the sensor-enabled Early Bird ...Learn More
InterValve acquired by Chinese heart valve maker
Chinese heart valve maker Venus Medtech announced the acquisition of InterValve, a US-based company whose V8 and TAV8 aortic ...Learn More
GE Additive, Stryker reach additive manufacturing partnership
A partnership agreement between General Electric's additive manufacturing division, GE Additive, and Stryker will bring GE's ...Learn More
HTG, Qiagen unit enter into statement of work
A statement of work has been signed by HTG Molecular Diagnostics and a Qiagen subsidiary to perform initial-phase ...Learn More
J&J Medical Device Cos., MUSC team up on infection prevention
Johnson & Johnson Medical Device Cos. ...Learn More
US patent issued for Microbot's device for shunt stenosis prevention
Microbot Medical has secured a patent from the US Patent and Trademark Office for its device to prevent shunt stenosis. ...Learn More
Limited launch of Haart 300 annuloplasty device announced by BioStable
The HAART 300 aortic annuloplasty device has been launched on a limited basis by Austin, Texas-based cardiovascular device ...Learn More
AdvaMed to meet with lawmakers on user fees
More than 50 medical device industry executives will meet with dozens of lawmakers in an effort organized by AdvaMed to ...Learn More
FDA clears TechLab's E. histolytica infection test
The FDA has given TechLab 510(k) clearance for its E. ...Learn More
How small the vastest of human catastrophes may seem at a distance of a few million miles.
...H.G. Wells, writer
Swedish IPO could bring in $45M for Bonesupport
Sweden-based Bonesupport intends to launch an initial public offering on the Swedish stock exchange, Nasdaq Stockholm, in ...Learn More
Funding round pulls in $5.5M for Irish medtech startup
The initial close of a round of Series B financing has pulled in $5.5 million for neoSurgical, an Irish medtech startup that ...Learn More
Siemens Healthineers, Fast-track Diagnostics partner on molecular Dx
A strategic alliance has been reached by Siemens Healthineers and Fast-track Diagnostics allowing the addition of ...Learn More
Becton Dickinson reaches single-cell analysis partnership with FlowJo
Becton Dickinson has formed a strategic relationship with FlowJo to market FlowJo's cloud-based data analysis software, ...Learn More
Analysts predict growth for gastrointestinal endoscopy devices market
The global market for gastrointestinal endoscopy devices is expected to see a compound annual growth rate of 5.09% through ...Learn More
Vertera Spine's cervical interbody fusion device obtains CMS reimbursement
A new ICD-10 code has been issued by the CMS covering the use of Vertera Spine's Cohere radiolucent porous interbody fusion ...Learn More
Study begins for new indication of DJO Global's bone growth stimulator
DJO Global launched a randomized, double-blind study for a new indication of its CMF OL1000 Bone Growth Stimulator, a ...Learn More
EU OKs 3-Tesla full-body scans with Biotronik's MR-conditional pacemakers
European regulators have given Biotronik CE mark approval for 3-Tesla full-body scans with its Edora, Evity and Enitra ...Learn More
FDA clears SI-BONE's iFuse-3D Implant
The FDA has given SI-BONE clearance for its iFuse-3D Implant, a 3D-printed titanium implant designed for use in fusion for ...Learn More
Biocartis' EGFR mutation test wins EU approval
European regulators have given Biocartis CE mark approval for its Idylla EGFR Mutation Test for lung cancer. ...Learn More
Good order is the foundation of all good things.
...Edmund Burke, statesman and orator
LifeScan enters partnership with Qualcomm unit, debuts next-gen app
Johnson & Johnson company LifeScan has reached a partnership agreement with Qualcomm Life to use Qualcomm's medical-grade ...Learn More
Public offering could pull in $65M for GenMark Diagnostics
A public offering of common stock has been launched by GenMark Diagnostics in hopes of obtaining $65 million. ...Learn More
Vertos Medical obtains $28M in funding round
A round of financing led by MVM Life Science Partners has brought in $28 million for Aliso Viejo, Calif.-based Vertos ...Learn More
Smart intubation device developer gets $20M boost
A round of funding led by Advanced Medical Technologies has pulled in $20 million for Israel- and Palo Alto, Calif.-based ...Learn More
Biodesix signs distribution deal with Positive Bioscience
An agreement has been reached by Biodesix allowing Positive Bioscience to distribute its GeneStrat and VeriStrat liquid ...Learn More
Report predicts growth for global spinal implants, devices market
An Allied Market Research report predicts the worldwide market for spinal implants and devices will hit $13.38 billion by ...Learn More
Why US first may be the new medical device development strategy
Increased regulatory hurdles in Europe and China could mean more medical device development focusing on the US market first. ...Learn More
BCBS of Vt. issues coverage policy for minimally invasive SI joint fusion
A written coverage policy has been established by Blue Cross and Blue Shield of Vermont for minimally invasive sacroiliac ...Learn More
Siemens Healthineers' PET/CT scanner wins FDA clearance
The FDA has granted Siemens Healthineers clearance for its Biograph Horizon Flow edition, a positron emission ...Learn More
Thermo Fisher secures clearances, registration for buprenorphine assay
Thermo Fisher Scientific has obtained clearance from the FDA to market its CEDIA Buprenorphine II assay, designed to ...Learn More
FDA clears syphilis assay from Bio-Rad
The FDA has given Bio-Rad Laboratories clearance for its BioPlex 2200 Syphilis Total & RPR assay, a fully automated ...Learn More
If there is no point in the universe that we discover by the methods of science, there is a point that we can give the universe by the way we live, by loving each other, by discovering things about nature, by creating works of art.
...Steve Weinberg, physicist
$140M debt refinancing announced by Spectranetics
An amendment to Spectranetics' existing credit facilities has increased the company's total credit facility to $140 million, ...Learn More
IPO could pull in $9M for Co-Diagnostics
An initial public offering of 1.3 million shares has been priced by Salt Lake City-based Co-Diagnostics in hopes of ...Learn More
Glytec, AgaMatrix partner on diabetes management platform development
AgaMatrix and Glytec have reached a partnership deal allowing the development of a cloud-based diabetes management platform ...Learn More
Zynex names new chief financial officer
Dan Moorhead has been tapped to serve as chief financial officer of Lone Tree, Colo.-based electrotherapy medical device ...Learn More
Medtronic aims to lower heart device infection rates with risk-sharing program
Over 140 US hospitals and clinics have signed up for Medtronic's risk-sharing program that seeks to lower infection rates ...Learn More
TransMedics advances perfusion device with US trials, successful procedures
Five US clinical trials are being sponsored by TransMedics for its Organ Care System, an ex vivo warm perfusion device, ...Learn More
CT/SPECT system debuted by Siemens Healthineers
The Symbia Intevo Bold CT and single-photon emission computed tomography system has been unveiled by Siemens Healthineers. ...Learn More
AirXpanders' AeroForm Tissue Expander System launched in US
The AeroForm Tissue Expander System has been released by AirXpanders to over 100 US medical institutions and health systems ...Learn More
AdvaMed fights for repeal of medical device tax amid health law uncertainty
AdvaMed and other groups lobbying for permanent repeal of the medical device tax have boosted their efforts amid uncertainty ...Learn More
Qiagen's 4th-gen tuberculosis blood test wins FDA nod
The FDA has given Qiagen approval for the QuantiFERON-TB Gold Plus test, the company's fourth-generation blood test designed ...Learn More
To accomplish great things, we must not only act, but also dream; not only plan, but also believe.
...Anatole France, writer and journalist
Boston Scientific pledges $19M to Irish endoscopy research, design facility
Boston Scientific has committed to invest approximately $19 million by 2020 in endoscopy research and in its new RoadRunner ...Learn More
Nexeon Medsystems announces shareholder offering of 5.3M shares
An upcoming offering of 5.3 million shares by company shareholders has been announced by Nexeon Medsystems, a Dallas-based ...Learn More
Bigfoot Biomedical announces acquisition of connected insulin pen tech maker
Patients Pending, along with its Timesulin connected insulin pen technology, have been acquired by artificial pancreas ...Learn More
Ascensia Diabetes, Insulet enter systems integration partnership
A strategic alliance has been reached by Ascensia Diabetes Care and Insulet to allow integration of Ascensia's Contour Next ...Learn More
Q3 revenue rises for Cantel Medical
Cantel Medical generated $192.1 million in revenue during its fiscal third quarter, up 10.6% from the same period a year ...Learn More
Study begins for Novocure's Optune device, Roche's Avastin
The first patient in a Phase II pilot study of a combination of Novocure's Optune tumor-treating fields delivery device and ...Learn More
Medtronic announces US launch of MiniMed 670G system
The MiniMed 670G system has been launched by Medtronic in the US for treating patients with type 1 diabetes. ...Learn More
FDA expands labeling for Hologic's 3D mammography system
The FDA has cleared Hologic for expanded labeling of its Genius 3D mammography system for use in routine breast cancer ...Learn More
List of reusable devices subject to validation data requirements issued by FDA
A list of reusable devices that will be required to have validated instructions for use and reprocessing validation data in ...Learn More
W.L. Gore's preperitoneal biomaterial hernia repair device wins FDA clearance
The FDA has given W.L. ...Learn More
Great things are done when men and mountains meet.
...William Blake, poet
Public offering could pull in $281.7M for Exact Sciences
An underwritten public offering of 7 million shares of common stock has been priced by Exact Sciences in hopes of obtaining ...Learn More
Funding round brings in $14.8M for ivWatch
A round of financing has pulled in $14.8 million for ivWatch, which makes the FDA-cleared ivWatch Model 400 device to ...Learn More
Interpace looks to obtain $10.5M in public offering
Interpace Diagnostics will launch a public offering of nearly 6.3 million shares of its common stock in hopes of obtaining ...Learn More
Cybersecurity startup Patientory gets $7.2M boost
Patientory, an Atlanta-based cybersecurity startup, has obtained $7.2 million in three days of equity crowdfunding involving ...Learn More
Study begins for Mallinckrodt's skin tissue graft
The first patient in a pivotal Phase III trial of the StrataGraft skin tissue graft has been enrolled by Mallinckrodt. ...Learn More
EU OKs Boston Scientific's deep brain stimulation system
Boston Scientific has obtained CE mark approval from European regulators for its Vercise Gevia Deep Brain Stimulation ...Learn More
Eko's smart heart monitor-stethoscope combo wins FDA clearance
The FDA has given Eko Devices 510(k) clearance for its Eko DUO smart heart monitor, a combination portable one-lead ...Learn More
Indian regulator seeks price controls for 4 medical devices
The health ministry of India was asked by the National Pharmaceutical Pricing Authority to add cardiac catheters, balloons, ...Learn More
FDA clears OrbusNeich's PTCA balloon dilatation catheters
OrbusNeich has obtained clearance from the FDA to market its Sapphire II PRO and Sapphire NC Plus percutaneous transluminal ...Learn More
House panel votes in favor of user fee reauthorization bill
A bill that would reauthorize user fee programs for medical devices, pharmaceuticals, generic drugs and biosimilars has ...Learn More
For more:
...Read AdvaMed President and CEO Scott Whitaker's statement commending the House Energy and Commerce Committee for its action o
Courage is resistance to fear, mastery of fear -- not absence of fear.
...Mark Twain, writer and humorist
Funding round pulls in $19.3M for Trice Medical
A round of Series C financing involving Smith & Nephew and other investors has brought in $19.3 million for King of Prussia, ...Learn More
Neuronetics gets $15M boost
A round of Series G financing has pulled in $15 million for Malvern, Pa.-based Neuronetics, a developer of noninvasive ...Learn More
ZipLine Medical obtains $12M in funding round
ZipLine Medical has raised $12 million in a round of Series E financing led by newly invested growth equity fund HighCape ...Learn More
Admetsys secures investment from T1D Exchange
T1D Exchange has made an investment of an undisclosed amount in artificial pancreas startup Admetsys as part of its ...Learn More
Global cervical total disc replacement device market poised for growth
A Persistence Market Research report predicts the worldwide market for cervical total disc replacement devices will reach ...Learn More
Data show positive results for GI Dynamics' EndoBarrier device
Data from an investigator-initiated study showed GI Dynamics' EndoBarrier device demonstrated reductions in HbA1c levels and ...Learn More
Health Canada OKs Medtronic's SureTune3 DBS software
Health Canada has granted Medtronic approval for its SureTune3 software, which facilitates physicians' decision-making in ...Learn More
Humanitarian device exemption regulations amended by FDA
Regulations for humanitarian device exemptions have been amended by the FDA to align with changes under the 21st Century ...Learn More
FDA expands use of Edwards' Sapien 3 heart valve
The FDA has given Edwards Lifesciences approval for the expanded use of its Sapien 3 Transcatheter Heart Valve, a device ...Learn More
Qiagen's CMV assay on QiaSymphony platform OK'd by FDA
Qiagen has obtained premarket approval from the FDA for its Artus CMV QS-RGQ molecular diagnostic kit on the fully ...Learn More
When you find your path, you must not be afraid. You need to have sufficient courage to make mistakes.
...Paulo Coelho, writer
Exchange offers, consent solicitations for Bard notes extended by BD
Exchange offers for up to $1.1 billion worth of outstanding C.R. ...Learn More
Earlens gets $118M boost
Menlo Park, Calif.-based Earlens has obtained $118 million in funding, with up to $45 million coming from a structured debt ...Learn More
Thermo Fisher enters co-marketing agreement with Biognosys
An agreement has been reached by Thermo Fisher Scientific and Swiss firm Biognosys to co-market Thermo Fisher's Orbitrap ...Learn More
Qiagen reaches 2 NGS assay agreements
Qiagen and Bristol-Myers Squibb have entered an agreement to look into the use of next-generation sequencing in the ...Learn More
Your fitness tracker could be misleading you
Your heart rate may be accurate on your fitness tracker, but the number of calories burned is significantly wrong, according ...Learn More
Data show positive results for Baxter's HDx therapy with Theranova dialyzer
Data from two studies presented at the Congress of the European Renal Association and European Dialysis and Transplant ...Learn More
Claret Medical's TAVR embolic protection system wins FDA clearance
Claret Medical has obtained clearance from the FDA through its de novo classification pathway for the Sentinel Cerebral ...Learn More
FDA extends UDI compliance dates for Class I, unclassified devices
The compliance date for unique device identifier requirements for Class I and unclassified medical devices has been extended ...Learn More
Roche's CMV test OK'd by FDA for use on cobas 6800/8800 systems
Roche Holding's cobas CMV test has been approved by the FDA for use on the fully automated cobas 6800 and cobas 8800 ...Learn More
FDA clears BD's intestinal bacteria test
The FDA has granted Becton Dickinson 510(k) clearance for its molecular test designed for the detection of harmful ...Learn More
Whatever can be done another day can be done today.
...Michel de Montaigne, philosopher
India, manufacturers in standoff over coronary stent prices
Medical device manufacturers Boston Scientific, Abbott Laboratories and Medtronic have filed paperwork to remove their most ...Learn More
Funding round pulls in $26.6M for Monteris Medical
A round of Series C financing has brought in $26.6 million for MRI-guided neurosurgical ablation systems developer Monteris ...Learn More
Israeli glaucoma treatment device maker gets $5M boost
A round of financing has pulled in $5 million for Israeli startup Belkin Laser, a portfolio company of the RAD Biomed ...Learn More
Arthromeda raises funds for hip replacement navigation system
A round of Series D financing has brought in an undisclosed amount for Lowell, Mass.-based Arthromeda. ...Learn More
TeraRecon announces merger with McCoy Medical
TeraRecon has acquired machine learning company McCoy Medical Technologies and is forming a new company focused on creating ...Learn More
Finland reschedules Nexstim's R&D loan repayments
The Finnish Funding Agency for Innovation has agreed to a three-year extension of the due date for Nexstim's research and ...Learn More
Trial shows positive results for W.L. Gore's septal occluders
A 664-patient, 63-site trial presented at the European Stroke Organisation Conference showed use of W.L. ...Learn More
Blue Shield of Calif. now covers Agendia's MammaPrint test
Blue Shield of California has released an updated medical policy that includes coverage for the use of Agendia's MammaPrint ...Learn More
Scientists create nonivasive deep brain stimulation technique
A technique called temporally interfering stimulation has been developed by MIT researchers to allow noninvasive stimulation ...Learn More
NICE to unveil online assessment tool for medical device, Dx companies
The Medtech Early Technical Assessment tool will be launched by the UK's National Institute for Health and Care Excellence ...Learn More
Once you become self-conscious, there is no end to it; once you start to doubt, there is no room for anything else.
...Mignon McLaughlin, journalist and writer
Boston Scientific exec: Medtech success is about category leadership
Boston Scientific will use category leadership as a strategy to succeed in the medical device industry as health care ...Learn More
European Investment Bank provides $22.6M loan facility to Stat-Dx
The European Investment Bank has granted Spanish molecular diagnostics firm Stat-Dx a loan facility worth approximately ...Learn More
Funding round pulls in $2.1M for CardioNXT
A round of equity financing has brought in $2.1 million for CardioNXT, a Westminster, Colo.-based medical device company ...Learn More
Expansion into global market eyed by Singapore medtech startups
A number of emerging medtech startups in Singapore are looking to expand into the global market as they secure funding from ...Learn More
New executive of international operations named by NuVasive
Skip Kiil, who has over 15 years of experience in the global medical technologies and life sciences business, has been ...Learn More
Data show positive results for Endologix's abdominal stent graft system
Thirty-day data from a 225-patient trial showed use of Endologix's Ovation abdominal stent graft system led to at least 28% ...Learn More
Glooko, Dexcom expand partnership with cloud integration
A partnership between Dexcom and digital diabetes management company Glooko has been expanded to allow cloud integration ...Learn More
FDA OKs Roche's companion Dx assay for Novartis' lung cancer drug
Roche Holding has obtained approval from the FDA for its Ventana ALK (D5F3) CDx Assay, which is intended for determining ...Learn More
FDA clears BioFire's FilmArray Respiratory Panel 2
The FDA has given BioMerieux affiliate BioFire Diagnostics clearance to market its FilmArray Respiratory Panel 2, which is ...Learn More
EU approves troponin assay from Singulex
European regulators have given Singulex the CE mark for its Sgx Clarity cTnl assay for use in quantitative measurement of ...Learn More
With confidence, you have won even before you have started.
...Marcus Garvey, political activist and publisher
Hyalex Orthopaedics gets $16M boost, announces leadership changes
A round of Series A financing involving Johnson & Johnson Innovation -- JJDC and other investors has brought in $16 million ...Learn More
Grail reaches merger deal with Cirina
A merger agreement has been reached by Illumina spinout Grail and Hong Kong-based startup Cirina, both of which are aiming ...Learn More
Funding round brings in $6.7M for Alesi Surgical
A round of funding has pulled in approximately $6.7 million for UK-based minimally invasive surgery technology developer ...Learn More
Irish medtech company obtains more than $5.8M in new funding
The EU has given Irish medtech company Altratech about $3.37 million in funding under the Horizon 2020 program. ...Learn More
Funding round pulls in $3.1M for Vertera Spine
A round of financing has brought in $3.1 million for Atlanta-based Vertera Spine, according to an SEC filing. ...Learn More
Study launched by Medtronic to create OIRD risk assessment scoring tool
A 1,650-patient study was launched by Medtronic to evaluate the effect of using capnography and pulse oximetry in ...Learn More
Exact Sciences' Cologuard scores reimbursement win from United Healthcare
A coverage determination guideline has been released by United Healthcare including coverage for the use of Exact Sciences' ...Learn More
FDA clears Masimo's O3 regional oximetry device for pediatric use
Masimo has obtained clearance from the FDA to market its O3 regional oximetry monitoring system with an O3 pediatric sensor, ...Learn More
AdvaMed, industry execs meet with commerce, HHS secretaries
AdvaMed President and CEO Scott Whitaker and 11 medtech industry executives met with Commerce Secretary Wilbur Ross and HHS ...Learn More
Augmenix's SpaceOAR system wins approval in Japan
The Japanese Ministry of Health, Labor and Welfare has given Augmenix Shonin approval for its SpaceOAR system. ...Learn More
Perseverance is not a long race; it is many short races one after another.
...Walter Elliott, clergyman
Funding round pulls in nearly $40M for Saluda Medical
A round of financing involving Medtronic, GlaxoSmithKline's Action Potential Venture Capital and other investors has brought ...Learn More
Offering could bring in $2.7M for Check-Cap
An offering of around 1.4 million shares of common stock involving a single health care institutional investor could bring ...Learn More
HemoSonics looks to keep expanding in N.C., exec says
HemoSonics President and CEO Timothy Fischer said the Charlottesville, Va.-based company, which has been acquired by French ...Learn More
Former Smiths Medical exec named DJO Surgical's global president
Jeffery McCaulley, former president and CEO of Smiths Medical, has been tapped by DJO Global to serve as the global ...Learn More
New director named to Merit Medical Systems' board
Thomas Gunderson, who worked at Pfizer's American Medical Systems for 12 years, has been tapped to serve on Merit Medical ...Learn More
Update to CONTEMPO Registry Study announced by InVivo Therapeutics
InVivo Therapeutics announced the inclusion of data from the Christopher & Dana Reeve Foundation North American Clinical ...Learn More
FDA clears Ra Medical's peripheral artery disease treatment device
Ra Medical Systems has obtained clearance from the FDA to market its DABRA System for treating peripheral artery disease. ...Learn More
Intuitive Surgical's da Vinci X surgical system wins FDA clearance
The FDA has given Intuitive Surgical 510(k) clearance for its latest da Vinci X Surgical System. ...Learn More
Quidel gets FDA clearance, CLIA waiver for influenza assay on analyzer
The FDA has granted Quidel a Clinical Laboratory Improvement Amendments waiver and 510(k) clearance for its Sofia Influenza ...Learn More
Recall of Zimmer Biomet's spinal fusion stimulators labeled as Class I by FDA
A recall initiated by Zimmer Biomet involving 33 select SpF Plus-Mini and SpF XL IIB implantable spinal fusion stimulators ...Learn More
There's nothing enlightened about shrinking so that other people won't feel insecure around you. We are all meant to shine, as children do.
...Marianne Williamson, writer
Offering could pull in $41M for Senseonics
An underwritten offering of common stock involving a group of institutional investors, including Roche Finance, has been ...Learn More
$100M shelf registration filed by Cancer Genetics
A shelf registration has been filed by Cancer Genetics with the SEC for an offering of up to $100 million in common stock, ...Learn More
Richardson's PACS Display business sold to Double Black Imaging
Double Black Imaging has acquired the PACS display business of Richardson Electronics for undisclosed terms. ...Learn More
Streck reaches distribution deal with Ngaio Diagnostics
Streck has signed an agreement with Ngaio Diagnostics allowing the latter to distribute its cell stabilization and molecular ...Learn More
Apple Watch detects atrial fibrillation using built-in technology
The Apple Watch can automatically detect atrial fibrillation (AF) using its built-in heart rate sensor and artificial ...Learn More
Data show positive results for Presbia's Flexivue Microlens
Preliminary data from a US pivotal clinical trial showed use of Presbia's Flexivue Microlens for correcting presbyopia led ...Learn More
ECRI releases cybersecurity guidance for medical devices
The ECRI Institute's newly released "Ransomware Attacks: How to Protect Your Medical Device Systems" guidance suggests ways ...Learn More
Roche announces launch of Accu-Chek Guide blood glucose meter
The Accu-Chek Guide System blood glucose meter has been launched by Roche Holding for use in streamlining diabetes ...Learn More
Enhancement to MESA 2 Deformity Spinal System debuted by K2M
The MESA 2 Cricket has been introduced by K2M as an enhancement to the company's MESA 2 Deformity Spinal System. ...Learn More
Pneumatic compression device for lymphedema launched by Tactile Systems
Tactile Systems Technology announced the launch of the Flexitouch system, a device intended for use in treating lymphedema ...Learn More
Stimwave's percutaneous injectable anchor system wins EU nod
European regulators have given Stimwave Technologies CE mark approval for its SandShark Percutaneous Injectable Anchor ...Learn More
Because I cannot do everything, I will not refuse to do the something that I can do.
...Edward Everett Hale, writer and minister
Illumina plans expansion in China, CEO says
Illumina is planning to expand operations in China, its biggest market outside of the US, following double-digit growth in ...Learn More
Private placement could pull in $13.3M for MRI Interventions
A private placement of 6.625 million units of common stock and stock purchase warrants could bring in $13.3 million for MRI ...Learn More
Lithomed to distribute Sanuwave's orthopedic products in Taiwan
Suwanee, Ga.-based Sanuwave Health has granted Lithomed a contract with a minimum order value of $500,000 to distribute its ...Learn More
Report predicts growth for global orthopedic devices market
A Global Market Insights report predicts the worldwide market for orthopedic devices will reach $53 billion by 2024 because ...Learn More
Fiscal Q4 revenue increases for Medtronic
Medtronic saw 4.6% year-over-year revenue growth during its fiscal fourth quarter ending April 28, generating over $7.9 ...Learn More
Study shows promising results for Provista's blood test for breast cancer
A study of 545 women ages 25 to 50 years showed that the use of Provista Diagnostics' Videssa Breast assay in breast cancer ...Learn More
Acelity announces US launch of negative-pressure wound therapy system
The Prevena Duo incision management system has been launched by Acelity in the US. ...Learn More
Gottlieb: FDA should focus on device-development process
The FDA does not have to speed up its approval process for medical devices and instead should focus on ensuring the ...Learn More
FDA clears enhancements to Bio-Rad's patient results-management software
The FDA has granted Bio-Rad Laboratories 510(k) clearance for enhanced options with its IH-Com patient results management ...Learn More
Japan OKs use of Quidel's influenza assay on immunoassay analyzer
Japan's Pharmaceuticals and Medical Devices Agency has given Quidel approval for its Sofia Influenza A+B Fluorescent ...Learn More
SmartBrief will not publish Monday
...In observance of Memorial Day in the US, SmartBrief will not publish Monday. Publication will resume Tuesday.
The real fountain of youth is hidden in the imagination you draw upon to face everyday challenges.
...Sophia Loren, actress
Viveve Medical gets $30M boost in loan agreement
A term loan agreement has been reached by Viveve Medical with CRG Servicing under which Viveve can initially borrow $20 ...Learn More
Funding round pulls in $7.5M for AI medical imaging startup
A round of seed funding has pulled in $7.5 million for Viz, an artificial intelligence medical imaging startup. ...Learn More
Integra LifeSciences reaches distribution deal with aapImplantate
Integra LifeSciences has agreed to distribute aapImplantate's LOQTEQ Distal Radius System in the US. ...Learn More
EarlySense creates cooperative venture with Chinese company
Israeli medical device company EarlySense and Chinese company Laxis has formed a cooperative venture through which ...Learn More
Report: Worldwide spine biologics market poised to expand
A Transparency Market Research report on the global spine biologics market showed minimal pain and invasiveness drive ...Learn More
Study begins for Medtronic's drug-coated balloon for end-stage renal disease
The first patient in a study of the In.Pact Admiral drug-coated balloon as a treatment for failing arteriovenous fistulas in ...Learn More
Trial shows positive results for Boston Scientific's Alair asthma device
A 284-patient postapproval study presented at the American Thoracic Society's annual meeting showed the use of Boston ...Learn More
Edico, Illumina reach partnership on sequencing data
A partnership has been reached by Edico Genome and Illumina to allow the addition of Edico's Dragen bioinformatics processor ...Learn More
FDA: Abbott's HeartMate II controller recall warrants Class I status
The FDA has labeled a recall of 28,882 HeartMate II System controllers initiated by Abbott Laboratories as Class I following ...Learn More
Japan OKs W.L. Gore's iliac branch endoprosthesis
The Japanese Ministry of Health, Labor and Welfare has granted W.L. ...Learn More
Our deepest fear is not that we are inadequate. Our deepest fear is that we are powerful beyond measure. It is our light, not our darkness, that most frightens us.
...Marianne Williamson, writer and activist
EnteroMedics buys maker of Gastric Vest System
BarioSurg, along with its Gastric Vest System, has been acquired by EnteroMedics for $2 million in cash, 1.38 million ...Learn More
Bain Capital's life sciences fund gets $720M boost
Private equity firm Bain Capital has closed its first life sciences investment fund, named Bain Capital Life Sciences, at ...Learn More
Funding round pulls in $16.8M for Anaconda Biomed
A round of Series A financing brought in approximately $16.8 million for Spanish preclinical stage medical device maker ...Learn More
Offering could bring in $3.5M for Great Basin
Great Basin Scientific is planning to launch a public offering of securities that could pull in $3.5 million in net ...Learn More
Vesiflo obtains $3.3M in funding round
An equity and mixed shelf round of financing involving 55 unnamed investors has pulled in $3.3 million for Vesiflo, ...Learn More
Sunshine Heart becomes CHF Solutions
Sunshine Heart has rebranded itself as CHF Solutions to better reflect its business direction toward a new commercial focus. ...Learn More
Meta-analysis shows positive results for GI Dynamics' EndoBarrier device
Data from a meta-analysis presented at the Digestive Disease Week meeting showed positive outcomes from the use of GI ...Learn More
Canada OKs Avacen Medical's pain relief, muscular relaxation device
Health Canada has given Avacen Medical approval for its Avacen 100, a device designed to provide muscular relaxation through ...Learn More
Yared discusses AdvaMed's advocacy, initial experience as chairman
CVRx CEO Nadim Yared talks about his experience as the new chairman of AdvaMed, as well as how AdvaMed is focusing on the ...Learn More
Trump seeks higher FDA user fees in 2018 budget request
President Donald Trump proposed higher user fees to offset lower FDA funding in his 2018 budget request, but Sen. ...Learn More
Restlessness is discontent -- and discontent is the first necessity of progress.
...Thomas Edison, inventor
Philips reaches deal to acquire RespirTech
Philips has agreed to pay an undisclosed amount for St. ...Learn More
Eastward Capital provides $20M facility to Organogenesis
Canton, Mass.-based advanced wound care innovation and technologies developer Organogenesis has secured a financing facility ...Learn More
Avery Dennison announces acquisition of Irish wound care device maker
Finesse Medical, an Irish company that makes products for wound care, has been acquired by US-based Avery Dennison for ...Learn More
QT Vascular negotiating deals for coronary assets
Singapore-based QT Vascular has announced that it is in talks with interested third parties to seek out potential deals for ...Learn More
Rosetta Genomics eyes sale of PersonalizeDx business
Rosetta Genomics has announced plans for a potential sale of its PersonalizeDx business, which markets fluorescence in situ ...Learn More
Report predicts growth for global spinal cord stimulation systems sales
A Meddevicetracker report predicts the global sales of spinal cord stimulation systems will reach $2.4 billion by 2021 with ...Learn More
AdvaMed unveils new tools to assess medical device value
AdvaMed has launched a new value initiative that includes extensive tables of questions to help medical device companies ...Learn More
Study shows positive results for Biotronik's home monitoring system
A 181-site randomized, controlled trial published in the European Heart Journal showed positive results for Biotronik's home ...Learn More
FDA clears Soterix Medical's IontoDC system
The FDA granted New York-based Soterix Medical 510(k) clearance for its IontoDC system, a device intended for introducing ...Learn More
Australia proposal would allow device approvals from some overseas regulators
Australia's Therapeutic Goods Administration has proposed the use of overseas marketing approval of medical devices to ...Learn More
Recall of Philips Respironics' ventilators labeled by FDA as Class I
A recall initiated by Royal Philips' Respironics business involving 20,690 units of its V60 noninvasive ventilator has been ...Learn More
Life is what we make it -- always has been, always will be.
...Grandma Moses, folk artist
Offering brings in $8M for Dextera Surgical
A public offering of 8,000 shares of Series B convertible preferred stock and related warrants has pulled in $8 million for ...Learn More
Amend Surgical gets funding for continued development, expansion
The Florida Institute for the Commercialization of Public Research has provided an undisclosed amount of funding to Alachua, ...Learn More
BioFire launches diagnostics development site in Utah
A 285,000-square-foot facility has been opened in Salt Lake City by BioMerieux's molecular diagnostics affiliate, BioFire ...Learn More
Zimmer Biomet reaches license deal with Bonutti Research
Zimmer Biomet and Bonutti Research have reached a license agreement allowing Zimmer Biomet to use two patent families ...Learn More
Chief medical officer named by Alcon
Stephen Lane has been tapped to serve as chief medical officer and global head of franchise clinical strategy at Alcon. ...Learn More
Study shows positive results for iRhythm's Zio monitor in AFib detection
A 116-patient study presented at the European Stroke Organisation Conference showed use of iRhythm Technologies' Zio ...Learn More
Cordis' interventional cardiology products unveiled at EUROPCR
Cardinal Health's interventional vascular arm, Cordis, unveiled at the annual EUROPCR conference its RAILWAY Sheathless ...Learn More
Early Warning Score debuted by Masimo for Root system
The Early Warning Score system has been launched by Masimo for use with its Root patient monitoring and connectivity hub. ...Learn More
Zimmer Biomet issues device field action on surgical robots
A voluntary medical device field action has been released by Zimmer Biomet for its Rosa Spine, Rosa Brain and Rosa One ...Learn More
EU OKs Ophtec's presbyopia-treating intraocular lens
European regulators have given Dutch company Ophtec CE mark approval for its Precizon Presbyopic intraocular lens, designed ...Learn More
SmartBrief Terms of Use and Privacy Policy
...We are updating our Terms of Use and Privacy Policy and we want to share the details with you.
My relationship with death remains the same -- I'm strongly against it.
...Woody Allen, director, screenwriter and actor
Vesalius Biocapital closes 3rd fund at more than $72.7M
Vesalius Biocapital, a Luxembourg-based biotech venture firm, has obtained over $72.7 million in the first closing of its ...Learn More
Funding round pulls in $5.26M for French medical robotics startup
A round of financing brought in approximately $5.26 million for Robocath, a French startup that makes the R-one robotic ...Learn More
Siemens, Relaymed partner to send POC test results to EHRs
An agreement has been reached by Siemens Healthineers and Relaymed to integrate Relaymed's cloud services with Siemens DCA ...Learn More
Thermo Fisher enters CDx development partnership with Agios
Thermo Fisher Scientific and Agios Pharmaceuticals have entered into an agreement under which a next-generation ...Learn More
Report issued on leading global bone cement market players
Mergers and acquisitions, as well as research and development investments, are likely to boost the revenue shares of DJO ...Learn More
Study shows positive results for Medtronic's Resolute Onyx stent
A 101-patient, multicenter study presented at the annual EuroPCR conference showed that use of Medtronic's 2-mm ...Learn More
XpandOrtho's electronic soft tissue balancing instrument cleared by FDA
XpandOrtho's electronic soft tissue balancing instrument has been granted clearance by the FDA for use in total knee ...Learn More
User fee reauthorization bill clears House subcommittee
Legislation that would reauthorize user fee programs for medical devices, pharmaceuticals, generic drugs and biosimilars has ...Learn More
EU suspends CE mark for GI Dynamics' EndoBarrier device
European regulators have suspended CE mark approval for GI Dynamics' EndoBarrier device because of nonconformances in the ...Learn More
Reimbursement 201: A Deeper Dive into the Reimbursement Landscape
June 28-29 | Washington, D.C.This next-level reimbursement workshop was created with the more advanced professional in mind. ...Learn More
Great artists are people who find the way to be themselves in their art. Any sort of pretension induces mediocrity in art and life alike.
...Margot Fonteyn, dancer
$14M deal to acquire Dx businesses from RPS Diagnostics finalized by Quidel
Quidel announced completion of an all-cash deal to buy RPS Diagnostics' InflammaDry and AdenoPlus diagnostic businesses for ...Learn More
HITRUST: WannaCry ransomware attack infected some medical devices
The global WannaCry ransomware attack has infected Siemens, MedRad and other unnamed medical devices, and Indicators of ...Learn More
Chinese medtech company buys Sharklet Technologies
Chinese medical device firm Peaceful Union has acquired Aurora, Colo.-based Sharklet Technologies for undisclosed terms. ...Learn More
Analysis: N. American artificial disc replacement market poised for growth
A GlobalData analysis predicts the North American artificial disc replacement market will reach $614.5 million by 2023 with ...Learn More
Report predicts growth for colonoscopy device market
A Technavio report predicts the market for colonoscopy devices will see a 4.63% compound annual growth rate through 2021, ...Learn More
Califf to work as adviser for Verily Life Sciences
A spokesperson for Verily Life Sciences said former FDA Commissioner Robert Califf will work as an adviser for the company ...Learn More
Analysis shows positive results for NeoTract's UroLift device
An analysis of a 206-patient randomized trial presented at the American Urological Association meeting showed use of ...Learn More
FDA clears BrainCool's temperature management system
The FDA has given Swedish company BrainCool AB clearance to market the IQool system, which uses focused anatomical zones to ...Learn More
Myoscience's knee osteoarthritis treatment device wins FDA clearance
The FDA has granted Myoscience 510(k) clearance for its Iovera device, a nonopioid and nonsystemic treatment for providing ...Learn More
Price calls for higher user fees, cuts in FDA's appropriations
HHS Secretary Tom Price, in a letter to Sen. ...Learn More
You can't use up creativity. The more you use, the more you have.
...Maya Angelou, writer and civil rights activist
DOD taps DePuy Synthes for $260M orthopedic supplies contract
The Department of Defense has granted Johnson & Johnson company DePuy Synthes a one-year contract, with three optional ...Learn More
Public offering pulls in $79.3M for Accelerate Diagnostics
A public offering of 2.75 million shares of common stock has brought in $79.3 million in gross proceeds for Accelerate ...Learn More
Calif. intraocular lens maker gets $7.3M boost
A round of equity financing involving 13 anonymous investors has pulled in $7.3 million for Irvine, Calif.-based LensGen, ...Learn More
Xtant Medical, Sites Medical reach licensing agreement
Sites Medical has signed an agreement giving Xtant Medical a license to use its OsteoSync Ti technology for undisclosed ...Learn More
New chief financial officer named by LivaNova
Thad Huston has been tapped to serve as chief financial officer of LivaNova effective May 20. ...Learn More
Data show positive results for Boston Scientific's Lotus heart valve
Data from a trial presented at the annual EuroPCR conference showed the use of Boston Scientific's Lotus heart valve in ...Learn More
FDA, EU approve Smart Meter's glucose monitoring system
The FDA has granted New York-based Smart Meter 510(k) clearance for its iGlucose blood glucose monitoring system, a ...Learn More
Life Spine announces full launch of lordotic expandable interbody solution
The PROLIFT lordotic expandable interbody solution has been fully launched by Life Spine. ...Learn More
Comments on device test labs accreditation pilot program sought by FDA
The FDA has issued a request for comments on its planned Accreditation Scheme for Conformity Assessment Pilot Program, which ...Learn More
EU OKs Shockwave Medical's Coronary Lithoplasty System
European regulators have given Shockwave Medical CE mark approval for its Coronary Lithoplasty system for use in combination ...Learn More
Reimbursement 101: A Primer on Medical Device Reimbursement
June 27-28 | Washington, D.C.During this workshop, you will be provided with the roadmap and practical applications to ...Learn More
You can have the nine greatest individual ballplayers in the world, but if they don't play together, the club won't be worth a dime.
...Babe Ruth, baseball player
Frameworks for diagnostics, medtech value assessment released by AdvaMed
A framework for communicating the value of diagnostic products to various health care stakeholders has been released by ...Learn More
For more:
...Learn more about the frameworks AdvaMed has unveiled for assessing the value of medtech and diagnostics.
Siemens' ultrasound business turnaround is paying off, exec says
The turnaround of Siemens Healthineers' medical ultrasound business, which involved establishing a new management team and ...Learn More
Silk Ventures raises $500M for venture capital fund
A $500 million fund has been closed by venture capital firm Silk Ventures for use in Series A and follow-on investments in ...Learn More
Akonni Biosystems gets $4M boost
Bridge financing worth $4 million has been secured by Frederick, Md.-based molecular diagnostics firm Akonni Biosystems. ...Learn More
Biomerics' $38.5M facility to bring 380-plus jobs to Salt Lake City
The Salt Lake City Department of Economic Development said cardiovascular device maker Biomerics is launching a $38.5 ...Learn More
Stryker opens office in England for Imorphics
Stryker announced the opening of a new office at Towers Business Park in Manchester, England, to accommodate its recently ...Learn More
New medicines could eliminate uterine fibroid surgeries
New medicines could provide a long-term management alternative to uterine fibroid surgeries over the next 10 years, ...Learn More
Data show positive results for Torax's magnetic sphincter augmentation device
Data from a study presented at Digestive Disease Week showed use of Torax Medical's Linx magnetic sphincter augmentation ...Learn More
Exactech's computer-assisted shoulder surgery solution wins FDA clearance
The FDA has given Exactech 510(k) clearance for its ExactechGPS Shoulder Application, a computer-assisted shoulder surgery ...Learn More
FDA grants HUD designation for Novocure's TTFields delivery system
Novocure has obtained a humanitarian use device designation from the FDA for its Tumor Treating Fields delivery system for ...Learn More
FDA clears Abbott's glucose test for use on i-STAT Alinity System
The i-STAT Glucose test from Abbott Laboratories has been granted 510(k) clearance for use on the i-STAT Alinity System. ...Learn More
There is a debt of service due from every man to his country, proportioned to the bounties which nature and fortune have measured to him.
...Thomas Jefferson, third US president
Options exercise brings total proceeds from BD's offerings to $4.95B
Offerings of common stock and depositary shares previously announced by Becton Dickinson are now expected to pull in $4.95 ...Learn More
Staar Surgical seeks to raise $200M in securities offering
A registration statement has been filed by Monrovia, Calif.-based Staar Surgical with the SEC for an offering of securities, ...Learn More
Medtronic to buy QT Vascular's nondrug-coated catheter for $28M
A $28 million option agreement has been reached by QT Vascular to sell its nondrug-coated Chocolate PTA Balloon Catheter to ...Learn More
Xtant gets $15M credit facility amendment, brings on restructuring officers
An amendment to a senior credit facility with affiliates of OrbiMed has been reached by Xtant Medical for financing worth up ...Learn More
Public offering could pull in $8M for Dextera Surgical
An underwritten public offering of Series B convertible preferred stock and warrants has been priced by Dextera Surgical in ...Learn More
Private placement brings in $2.6M for Covalon
A private placement of 931,121 units of common stock and stock purchase warrants has brought in $2.6 million for Covalon ...Learn More
Senseonics reaches R&D licensing deal with TypeZero
Senseonics and TypeZero Technologies have reached a research and development licensing agreement to allow integration of ...Learn More
Hip replacement positioning system debuted by Corin
The Optimized Positioning System has been launched by the Corin Group for use in hip replacement procedures. ...Learn More
Cook Medical's esophageal atresia treatment device wins FDA nod
Cook Medical has obtained approval from the FDA for its Flourish Pediatric Esophageal Atresia Anastomosis, a device designed ...Learn More
Format for collecting data on medtech prices finalized by Indian regulator
A new format has been finalized by India's National Pharmaceutical Pricing Authority to help in collecting data for ...Learn More
If you hear a voice within you saying, 'You are not a painter,' then by all means paint ... and that voice will be silenced.
...Vincent van Gogh, artist
Funding round pulls in $45M for Impulse Dynamics
A round of financing led by Goldstone Investment has brought in $45 million for Impulse Dynamics, a German company that ...Learn More
1-for-8 reverse stock split announced by NeuroMetrix
A 1-for-8 reverse stock split was declared by NeuroMetrix effective Thursday in a move to comply with the Nasdaq capital ...Learn More
Innovatus affiliate provides $17M loan to TransEnterix
A term loan worth $17 million has been secured by TransEnterix from an affiliate of Innovatus Capital Partners. ...Learn More
IPO could bring in $8.4M for Endra Life Sciences
An initial public offering of 1.68 million units of common stock and stock purchase warrants could pull in $8.4 million for ...Learn More
Mich. medical device startup gets $1.5M boost
A round of Series A financing led by the Michigan Angel Fund has pulled in $1.5 million for Holland, Mich.-based medtech ...Learn More
24 medtech, drug delivery companies join J&J's Toronto incubator
Twenty-four medical device and drug delivery companies have been accepted by Johnson & Johnson for its JLABS @ Toronto, an ...Learn More
Data show positive results for Medtronic's Micra pacemaker
A study of postapproval registry data presented at the annual scientific sessions of the Heart Rhythm Society showed ...Learn More
Team develops biosupercapacitors for powering medical devices
Researchers from UCLA and the University of Connecticut reported in the journal Advanced Energy Materials about the ...Learn More
Senate panel votes in favor of user fee reauthorization bill
A bill that would reauthorize user fee programs for medical devices, pharmaceuticals, generic drugs and biosimilars has ...Learn More
FDA clears Quidel's Clostridium difficile test
The FDA has given Quidel 510(k) clearance for a molecular assay that runs on its Solana platform for the qualitative ...Learn More
It is easier to live through someone else than to become complete yourself.
...Betty Friedan, writer and feminist activist
Offering could pull in $79.3M for Accelerate Diagnostics
An upsized public offering of common stock has been priced by Accelerate Diagnostics in hopes of raising about $79.3 ...Learn More
Cook Medical's vertebroplasty products acquired by IZI Medical
Cook Medical has sold its vertebroplasty product line to IZI Medical Products, the interventional products platform of Shore ...Learn More
Intrinsic Therapeutics gets $49M boost
A round of debt and equity financing has pulled in $49 million for Boston-based Intrinsic Therapeutics. ...Learn More
Bridge Bank provides $10.5M in debt financing to Providence Medical
Debt financing worth $10.5 million has been secured from Bridge Bank by Walnut Creek, Calif.-based tissue-sparing cervical ...Learn More
Cardiff International to pay $6M for MedicaMetrix
Cardiff International has reached a $6 million all-stock agreement to buy MedicaMetrix, developer of the CE-marked ...Learn More
Treace Medical obtains $5.9M in funding round
A round of equity financing involving 38 unnamed investors has brought in $5.9 million for Ponte Vedra Beach, Fla.-based ...Learn More
Study shows positive results for Boston Scientific's ApneaScan
A study presented as an abstract at the Heart Rhythm Society Annual Scientific Sessions showed Boston Scientific's ApneaScan ...Learn More
Varian Medical's proton therapy system wins approval in Japan
The Japanese Ministry of Health, Labor and Welfare has granted Varian Medical Systems Shonin approval to market its ProBeam ...Learn More
Medtronic's MR-conditional quadripolar CRT-Ps secure FDA nod
The FDA has granted Medtronic clearance for its MR-conditional quadripolar cardiac resynchronization therapy pacemakers for ...Learn More
EU OKs Abbott's sensor-enabled ablation catheter
European regulators have given Abbott CE mark approval for its sensor-enabled TactiCath contact force ablation catheter, a ...Learn More
The longer I live, the more beautiful life becomes.
...Frank Lloyd Wright, architect
Funding round pulls in $20M for Conventus Orthopaedics
A round of equity financing led by Deerfield Management has brought in $20 million for Maple Grove, Minn.-based Conventus ...Learn More
Becton Dickinson, UniteOR reach systems integration deal
Becton Dickinson and UniteOR have agreed to allow integration of UniteOR's cloud-based surgical tray tracking and vendor ...Learn More
Siemens Healthineers, Imricor partner to improve arrhythmia treatment
A strategic partnership has been reached by Siemens Healthineers and Imricor Medical Systems, an interventional MRI ...Learn More
Report predicts growth for global arthroscopy, sports medicine device sales
A Meddevicetracker report predicts the worldwide sales for arthroscopy and sports medicine devices will reach $6.5 billion ...Learn More
Study shows promising results for Intento's stroke rehabilitation device
A clinical trial published in the Archives of Physical Medicine and Rehabilitation showed promising results for Intento's ...Learn More
3rd-gen Impella CP heart pump unveiled by Abiomed
The third-generation Impella CP heart pump was unveiled by Abiomed at the Society for Cardiovascular and Angiography ...Learn More
Cook Medical announces launch of next-gen wire guide
The next-generation Acrobat 2 calibrated tip wire guide has been launched by Cook Medical for use in facilitating ductal ...Learn More
Gottlieb confirmed by Senate to head FDA
Scott Gottlieb, a physician who has been a venture capitalist and a conservative expert on health care policy, was confirmed ...Learn More
For more:
...Read the AdvaMed news release congratulating Scott Gottlieb on his confirmation as FDA commissioner.
Whitaker discusses industry efforts to repeal medical device tax
AdvaMed President and CEO Scott Whitaker expressed optimism that the medical device tax will be repealed this year, likely ...Learn More
Boston Scientific's line of ICD, CRT-D systems wins FDA approval
Boston Scientific's Resonate line of implantable cardioverter defibrillators and cardiac resynchronization therapy ...Learn More
Always be a first-rate version of yourself, instead of a second-rate version of somebody else.
...Judy Garland, singer and actress
Offerings could pull in $4.5B for Becton Dickinson
Registered offerings of common stock and depositary shares have been launched by Becton Dickinson in hopes of raising $4.5 ...Learn More
Accelerate Diagnostics to float 2.5M shares in public offering
Accelerate Diagnostics has announced commencement of an underwritten public offering of 2.5 million shares of its common ...Learn More
Devicare obtains $3.3M in seed funding round
A round of seed financing has brought in almost $3.3 million for Devicare, a Spanish company that makes remote monitoring ...Learn More
VP of professional development named by Titan Spine
Ed Graubart, who has over 27 years of sales team infrastructure and personnel building experience in the spine field, has ...Learn More
10 new crowdfunded health devices that will intrigue you
With crowdfunding websites like Kickstarter and Indiegogo, companies can obtain the funding for ideas they want to come to ...Learn More
France grants reimbursement for Abbott's glucose monitor
The French Health Ministry has given Abbott national reimbursement for its FreeStyle Libre, a glucose monitoring technology ...Learn More
Study advances for InVivo Therapeutics' Neuro-Spinal Scaffold
The 15th patient in a trial of InVivo Therapeutics' Neuro-Spinal Scaffold has been enrolled by Oregon Health & Science ...Learn More
3 cardiac technologies launched by Biotronik
Biotronik has debuted the Sentus ProMRI, a quadripolar left ventricular lead approved by the FDA for use with devices ...Learn More
Elekta unveils MR-radiation therapy system
The Elekta Unity MR-radiation therapy system was unveiled by Elekta at the annual meeting of the European Society for ...Learn More
Senate panel releases amended user fee reauthorization bill
An updated version of the user fee reauthorization bill has been released by the Senate health committee ahead of its ...Learn More
EU OKs St. Jude Medical's smartphone-compatible cardiac monitor
European regulators have given Abbott subsidiary St. ...Learn More
Medical Device Complaints, MDRs & Reports Workshop
May 23-24 | Washington, D.C. ...Learn More
The real affliction of old age is remorse.
...Cesare Pavese, writer
BD opens exchange offers, consent solicitations for C.R. Bard notes
Offers have been announced by Becton Dickinson to swap all outstanding notes issued by C.R. ...Learn More
Funding round pulls in $20M for Visunex Medical Systems
A round of Series B financing has brought in $20 million for Fremont, Calif.-based Visunex Medical Systems, a maker of ...Learn More
CartiHeal gets $18.3M boost
Israel-based CartiHeal has raised $18.3 million in a round of financing led by investment firm aMoon Partners. ...Learn More
Funding round brings in $2.5M for Swiss blood collection device maker
DBS System, a maker of blood collection devices based in Switzerland, has raised approximately $2.5 million in a round of ...Learn More
Rosetta Genomics, Cytolog reach distribution deal for thyroid test
Cytolog Laboratories has agreed to exclusively distribute Rosetta Genomics' RosettaGX Reveal thyroid test in Brazil for ...Learn More
Data show positive results for CytoSorbents' blood purification tech
Data from a trial presented at the American Association for Thoracic Surgery's centennial conference showed that use of ...Learn More
Linear accelerator system debuted by Varian Medical Systems
The Halcyon linear accelerator system has been unveiled by Varian Medical Systems for use in image-guided volumetric ...Learn More
CareTaker's connected BP, heart rate sensor wins expanded FDA clearance
CareTaker Medical's CareTaker wearable blood pressure and heart rate sensor has received expanded clearance from the FDA to ...Learn More
EU device, IVD rules set for implementation this month
New regulations for medical devices and in vitro diagnostics in Europe are scheduled to take effect beginning May 25 ...Learn More
FDA clears Crospon's next-gen Endoflip system with Flip topography module
The FDA has given Crospon 510(k) clearance for its next-generation Endoflip system, Endoflip 2.0, with Flip topography ...Learn More
2017 Women's Executive Network Conference
June 20 | Cambridge, Mass.Across this unique one-day event, we'll feature a range of executives from across the medical ...Learn More
People will always follow a good example; be the one to set a good example.
...Anne Frank, diarist
Siemens considering listing options for health care unit, CFO says
Siemens is weighing several listing options for its health care business, Siemens Healthineers, including a spinoff, an ...Learn More
Exec provides updates on Stryker's current state, strategies
Stryker generated more than $11 billion in sales last year and has been expanding at the medtech market's high end, Chairman ...Learn More
Report: Medtronic, Boston Scientific lead medtech acquisitions
Acquisitions activity in the medical device industry since 2012 has been led by Medtronic, which bought 15 medtech firms, ...Learn More
Draft coverage determinations issued by Palmetto for molecular Dx
Draft local coverage determinations have been released by Medicare contractor Palmetto GBA, giving positive decisions for ...Learn More
Study begins for door to unloading with Abiomed's Impella CP system
The first patient in a prospective feasibility study of door to unloading using the Impella CP system in patients with acute ...Learn More
FDA clears Faxitron's RFID lesion localization system
The FDA has granted Tucson, Ariz.-based Faxitron clearance to market its LOCalizer radio frequency identification lesion ...Learn More
Carestream's anti-scatter software wins FDA clearance
Carestream Health's SmartGrid software has been granted 510(k) clearance by the FDA. ...Learn More
ACA replacement bill that includes device tax repeal clears House
The American Health Care Act, a bill aimed at repealing the medical device tax and other sections of the Affordable Care ...Learn More
Recall of Medtronic's HVAD splice kit labeled by FDA as Class 1
A recall initiated by Medtronic involving select units of its HeartWare Splice Kits has been classified by the FDA as Class ...Learn More
Acutus Medical's percutaneous catheter introducer cleared by FDA
The FDA has given California-based Acutus Medical clearance for its AcQGuide Steerable Sheath, a percutaneous catheter ...Learn More
Integrating Human Factors Into Medical Device Design Control And Beyond Workshop
June 6-7 | Golden Valley, Minn.Maintaining effective design control procedures is a key element of the quality system ...Learn More
You move totally away from reality when you believe that there is a legitimate reason to suffer.
...Byron Katie, writer and speaker
LivaNova announces $72M buyout of Caisson Interventional
London-based LivaNova has agreed to buy the remaining 51% stake it does not already own in Maple Grove, Minn.-based Caisson ...Learn More
GI Dynamics considers listing on AIM market
GI Dynamics is looking to trade on the AIM market of the London Stock Exchange with the help of Allenby Capital, a nominated ...Learn More
Funding round pulls in $76.5M for Outset Medical
A round of Series C financing brought in $76.5 million for San Jose, Calif.-based commercial-stage medtech company Outset ...Learn More
Medtronic to invest $6.5M in S.C. facility expansion
Medtronic announced plans for a $6.5 million expansion project that will add a production line and new equipment to its ...Learn More
Texas diagnostics startup obtains $2M in funding round
A round of funding has pulled in $2 million for EverlyWell, an Austin, Texas-based startup that offers direct-to-consumer ...Learn More
Visionary Venture Fund gets boost from first financing round
Technology and life sciences accelerator OCTANe and Visionary Venture Fund announced completion of the first financing round ...Learn More
Trial seeks to assess Alzheimer's disease treatment with focused ultrasound
A clinical trial has been launched by Canadian researchers to evaluate the use of focused ultrasound, particularly ...Learn More
FDA clears Interscope's endoscopic resection tool
The EndoRotor endoscopic resection tool, developed by Worcester, Mass.-based startup Interscope for gastroenterology and ...Learn More
Warning on Medtronic's NavLock Tracker released by FDA
The FDA has issued a warning to health care providers concerning reports of patient injuries, including two deaths, ...Learn More
Baxter receives FDA guidance on pathway for peritoneal dialysis tech
Baxter said it will use the regulatory pathway for a combination product for its new home peritoneal dialysis solution ...Learn More
We must believe that we are gifted for something, and that this thing, at whatever cost, must be attained.
...Marie Curie, physicist and chemist


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In the News
Ex-Duke football player: How I had my heart attack (and what you can learn from it)
By: Fox News | July 2016

Heart disease is the number one cause of death for both men and women in the United States. Claiming approximately 1 million lives per year, heart attacks alone strike someone every 43 seconds. On January 20, 2014, that someone was me. 

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Robotic prostatectomy with the da Vinci is one of the latest surgical innovations used to treat prostate cancer.  

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Confronting A Global Radiotherapy Shortfall
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As much as 60 percent of the world’s population does not have access to a cost-effective form of cancer treatment and management therapy that saves lives and improves clinical outcomes. 

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Plasma Makes Wounds Heal Quicker
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Many people suffer from skin disorders. Open wounds are a particularly acute problem, especially among the elderly. PlasmaDerm, a new medical technology solution, uses plasma to facilitate faster healing of wounds.

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