News

St. Jude wins EU nod for device used in coronary stent placements

Stryker looks to continue acquisition trail, CEO says

Biohit strikes Dx supply deal with Hefei Medicine

Former Zimmer exec joins ConforMIS as SVP of operations

EU approves Tryton Medical's side-branch short stent

Devon gains approval for wound-therapy device in Europe

Smallest FDA-approved device implanted at Mich. eye facility

Prosthetist invents technology to cushion amputated bone

NinePoint's esophageal imaging device debuts in U.S.

FDA clarifies existing guidance on medical-device appeals

AdvaMed 2013 Company Presentations deadline is May 24

Helping medical technology professionals keep pace with regulatory and compliance issues

Divide each difficulty into as many parts as is feasible and necessary to resolve it.

Life Spine gets FDA OK for next-gen Iris cervical plate

Roche considers divestment of glucose meter business, sources say

Funding round pulls in $10M for SpineVision

Mass. thermal therapy device firm raises $5.5M in funding round

EU approves Elixir Medical's bioresorbable heart stent

Natera taps Echevarne to offer prenatal test in Spain

Sales without sales reps, a new pilot from Wright Medical worth watching

Researchers seek FDA approval for diabetes cell transplants

Olympus to debut advanced ultrasound processor at Fla. event

Roche's companion Dx for lung cancer drug wins FDA nod

Global Orthopaedic gains 510(k) clearance for hip implant

AdvaMed 2013 Company Presentations deadline is May 24

Advertising and Promotion of Medical Devices

If you look for truth, you may find comfort in the end: if you look for comfort you will not get either comfort or truth.

Medtech sector poised to see M&A growth this year, report says

Edwards announces $750M share repurchase program

Mass. maker of infectious-disease tests obtains $7M

Covidien gets new head of corporate communications

Eucomed

Suspension of Italian medtech price cuts upheld

Experts skeptical of EU medtech proposal

French firm gains OK for human heart trial in 4 countries

Trial begins for St. Jude's next-gen renal denervation device

Feds working to improve device-review process, FDA official says

FDA clears iCRco's digital mammography system

AdvaMed 2013 Company Presentations deadline is May 24

Premarket Approval (PMA) Submissions Workshop

That which is always within our reach is always the last thing we take; and the chances are, that what we can do every day, we never do at all.

Theragenics receives takeover bid of up to $71.4M from Juniper

6 medtech startups to receive funds from Tenn. accelerator

Dx sales drive revenue growth for Sequenom in Q1

Nanosphere strikes deal to bring its Dx products to Japan

Health tech assessment agency in Ireland names new chairman

Iraq War vet is first soldier to get a double arm transplant

Low-dose anticoagulant OK with aortic valve replacement

BIOLASE's tissue laser gets FDA OK for orthopedic, podiatric use

AdvaMed aims to engage medtech employees in policy debate

FDA OKs Sorin's Smartview heart implant monitoring tool

AdvaMed 2013 Company Presentations deadline is May 24

Medical Device Reimbursement Workshop

Correction

Be not angry that you cannot make others as you wish them to be, since you cannot make yourself as you wish to be.

St. Jude gains FDA OK for next-gen heart defibrillators

Report finds more large medtech companies buying into China

BPL Medical lands $20M investment from Goldman Sachs

BG names new CEO, boosts sales for diagnostic test

EU approves Boston Scientific's 3D heart mapping tool

Abbott wins approval for hemoglobin test in Europe

Use of 3D printers to make prostheses becomes more widespread

Expandable corpectomy spacer from Globus is available

FDA proposes changes to biological review of medical devices

New diabetes management package from Glooko gets FDA clearance

AdvaMed 2013 Company Presentations deadline is May 24

Investigational Device Exemption (IDE) Submission Workshop

Sometimes you have to play a long time to be able to play like yourself.

NP Medical wins FDA nod for infusion therapy device

Vermillion targets $31.5M from funding round

Rainbow Medical reportedly lands $10M investment from Sony

Diagnostic-test maker gets additional $4.2M funding boost

St. Jude's next-gen heart defibrillators gain CE mark

Boston Scientific device outperforms warfarin in atrial fibrillation study

Trial is under way for SynapDx's early autism test

New lightweight exoskeletons get closer to market

FDA OKs Combat Medical's device to stem heavy bleeding

FDA approves Signostics' handheld ultrasound device

510(k) Submissions Workshop

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Optimism is essential to achievement and it is also the foundation of courage and true progress.

X-Spine wins FDA nod for facet joint fusion device

ICU Medical considers putting itself up for sale, sources say

Mass. molecular Dx firm secures $28M loan

Nanosphere obtains $27M in financing, posts Q1 revenue growth

Medtech industry's image improves among patient groups

Russia reviews system for medical-device registration

The strange case of the diabetes market

Heart muscle patch behaves like natural tissue

MRI software from Siemens lands 510(k) clearance

Ind. lawmakers query VA Affairs chief on effects of device tax on department

FDA OKs Arcos' device to help treat severe burn patients

AdvaMed 2013 Company Presentations deadline is May 24

Recalls from A to Z: Regulations, Decisions, Procedures and Best Practices

To become truly great, one has to stand with people, not above them.

Exactech's occipital spinal device gains FDA clearance

Quidel to expedite test development with BioHelix deal

NuVasive pays $4.5M for spine-implant supplier

Ocon Medical obtains $1.68M from investors

Mazor strikes supply deal for robotic device in India

Eucomed

Impulse launches implantable pulse generator in Europe

Simple walking assist makes a big difference for stroke patients

Brain-controlled exoskeleton to debut at 2014 World Cup

FDA seeks input on medical device labeling proposal

FDA sets review date for SpinalMotion's artificial disc

AdvaMed 2013 Company Presentations deadline is May 24

Helping medical technology professionals keep pace with regulatory and compliance issues

All truly wise thoughts have been thought already thousands of times; but to make them truly ours, we must think them over again honestly, till they take root in our personal experience.

Medtronic gains FDA OK for heart resynchronization device

Zimmer to boost knee-product portfolio with acquisition

Early warrants call expected to bring in $10.4M for InVivo

GE picks 2 execs from health care division for VP roles

Spanish firm gets $22.1M boost for diagnostic system

First human trial of Boston Scientific's ablation device closes

Experts modify cancer Dx device to detect infectious diseases

Pediatric use of Masimo's respiratory monitor wins FDA nod

FDA outlines key medical device projects for 2013

Abiomed readies PMA application for Impella heart pump

Physician Payment Sunshine Act for Medical Devices

See AdvaMed-MTLI's schedule of courses

Not everything that is faced can be changed. But nothing can be changed until it is faced.

Mauna Kea's optical biopsy miniprobe gets FDA OK

Texas investor to pump $805M into biopharma, medtech firms

Diagnostics-maker gets $20M funding boost

Channel raises $9.7M in funding round led by Boston Scientific

Diagnostic product sales boost Becton's revenue in Q2

NICE takes over role of U.K.'s health tech adoption center

Vaxxas readies tiny vaccine-delivery patch for clinical use

Portable ultrasound scanner from Alpinion arrives in U.S.

FDA OKs J&J's sedation device used during colonoscopies

Inx submits FDA application for hemorrhoids device

Medical Device Complaints, MDRs and Reports

Molecular Diagnostics and the Changing Landscape: Considerations and Implications

Human beings, who are almost unique in having the ability to learn from the experience of others, are also remarkable for their apparent disinclination to do so.

Smith & Nephew acquires Indian firm, plans $300M stock buyback

Mass. heart device firm obtains $11M in debt financing

Atossa enters breast cancer Dx partnership with Millennium

EU approves 2 nerve-repair devices from AxoGen

Haemonetics to transfer disposable-product manufacturing to Mexico

St. Jude proceeds with study of next-gen CRT defibrillator

Quadriplegic patient moves robotic arm with her mind

Device to monitor lung function wins innovation contest

Olympus makes flexible HD bronchoscope available in U.S.

Senator voices continued support for repeal of device tax

Premarket Approval (PMA) Submissions Workshop

Advertising and Promotion of Medical Devices

Deliberation is the function of many; action is the function of one.

InterValve gets FDA OK for balloon catheter

Series E funding round pulls in $54.6M for Natera

Microarray Dx firm seeks $3.7M in financing

Industry veteran joins Sanuwave as CMO

TriReme's torqueable catheter wins approval in Japan

Report: Brazilian imaging market could be worth $919.7M in 4 years

Health care giants unite to turn Big Data into medtech savings

Study of Profound's prostate cancer ablation device advances

Ekso Bionics seeks to develop next-gen powered exoskeleton

Tiny heart-assist device demonstrates positive trial results

FDA gives Sorin nod on trial for sutureless aortic valve

Medical Device Complaints, MDRs and Reports

Premarket Approval (PMA) Submissions Workshop

A peacefulness follows any decision, even the wrong one.

Jawbone expands wearable-tech footprint with BodyMedia buy

Siemens sets up ultrasound manufacturing plant in Pa.

Rindex obtains license for AF prediction technology

Assay sales drive revenue growth for Luminex in Q1

Eucomed

St. Jude wins EU approval for quadripolar pacemaker

Study of Medtronic's aortic stent graft kicks off

NovoSource's knee-replacement device lands FDA clearance

Texas pediatric hospital adopts Philips' PET/MRI scanner

Senator sees tax reform as "a major vehicle" for device tax repeal

FDA widens clearance for NxStage's hemodialysis system

510(k) Submissions Workshop

Investigational Device Exemption (IDE) Submission Workshop

Three grand essentials to happiness in this life are something to do, something to love, and something to hope for.

Teleflex's vascular positioning device wins FDA nod

IPO pulls in about $10.5M for SpineGuard

Calif. atrial fibrillation device firm obtains $25M

RAND board member joins NxStage as chairman

Tech advances will drive global MRI market growth, report says

New-device market for imaging hit $24.1B in 2012

Firm seeks NIH grant to conduct study of epilepsy Dx tool

Test can ID 13 diseases in single blood sample

Bodelin readies microscope that works with Apple devices

FDA OKs intervertebral body fusion system from Spine Wave

Medical Device Complaints, MDRs and Reports

Recalls from A to Z: Regulations, Decisions, Procedures and Best Practices

I'm slowly becoming a convert to the principle that you can't motivate people to do things, you can only demotivate them. The primary job of the manager is not to empower but to remove obstacles.

J&J unit gets supplemental FDA OK for hip replacement device

Calif. device startup obtains almost $6M from investors

Device, pharma sales drive Q2 sales growth for Covidien

Zoll Medical announces relocation plan in Calif.

Forum considers global UDI framework for medtech

Calif. spinal device firm sets up shop in Japan

EU awards $7.8M for kidney transplant biomarker development

CytoVas forges cardiovascular Dx partnership with Becton

Device designed to ID multiple biomarkers in exhaled breath

FDA expands clearance for NinePoint's imaging device

Molecular Diagnostics and the Changing Landscape: Considerations and Implications

Physician Payment Sunshine Act for Medical Devices

I don't want to get to the end of my life and find that I have just lived the length of it. I want to have lived the width of it as well.

Olympus' 3D imaging device for laparoscopic surgery gets FDA OK

Female angel investors in biotech, health sectors doubled in 2012

X-ray device sales help boost Q2 revenue, profit for Varian

Former Covidien exec joins InspireMD as VP

London teen is first to receive advanced i-limb hand in the U.K.

CardioDx strikes deal to bring artery disease assay to India

Experts: Smart card system useful in tracking radiation dose

Respiratory device from ResMed makes U.S. debut

What Baucus' retirement could mean for device tax repeal efforts

Southern Spine wins U.S., EU nod for spinal fixation device

Medical Device Complaints, MDRs and Reports

Join the AdvaMed-MTLI LinkedIn group!

I wish to suggest that a man may be very industrious, and yet not spend his time well. There is no more fatal blunderer than he who consumes the greater part of life getting his living.

Senator blocks confirmation vote for Tavenner to head CMS

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Thermo Fisher delays share repurchase program

CEO of Textron joins Medtronic as director

Brazil to reform health care assessment and testing standards

Worldwide X-ray device market could exceed $5.25B in 5 years

Building the "eBay of medical devices": A conversation with Aptitude's Troy Kirchenbauer

Trial under way for Alumend's device to treat artery disease

Device to evaluate quality of stored blood is in development

FDA moves to boost patient involvement in device, drug regulation

FDA to use smartphone app in device safety monitoring

FDA approves CDC flu virus test for emergency use

Helping medical technology professionals keep pace with regulatory and compliance issues

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Life isn't about finding yourself. Life is about creating yourself.

InspireMD gets FDA OK to launch study of MGuard stent

Quest Diagnostics signs $450M share-repurchase agreement

Wash. maker of ultrasound-based stroke device eyes $8.2M

Teleflex unit strikes supply deal for laryngeal masks

Eucomed

UK industry seeks to address future medtech expertise needs

Medtronic teams with drug firm on atrial fibrillation study

Cervel raises funds for transcranial magnetic therapy studies

MIT student devises new technology for socket design

Esaote makes first U.S. installation of G-scan Brio MRI scanner

FDA holds meeting on global cardiovascular registry consortium

Molecular Diagnostics

See AdvaMed-MTLI's schedule of courses

Whoever is in a hurry shows that the thing he is about is too big for him.

Aspect Imaging's wrist MRI scanner gains FDA clearance

Public stock offering pulls in $22.6M for InspireMD

Calif. catheter device startup raises $660K

Taxes exacerbate Brazil's medtech trade deficit, industry group says

German molecular Dx company obtains $16.3M in financing

Market for refurbished devices could hit $9B in 5 years

Indian surgery center creates prosthetic foot and ankle bones

Researchers develop wireless brain-computer interface

Texas cancer facility adopts Elekta's linear accelerators

Lawmakers call for immediate action on medical device tax

Medical Device Complaints, MDRs and Reports

Join the AdvaMed-MTLI LinkedIn group!

The fear of being laughed at makes cowards of us all.

Sanomedics announces $3M buyout of Prime Time Medical

Fla. maker of sleep apnea testing device obtains $32.2M

Calif. heart device startup eyes $7M in funding round

4 medtech firms sign supply deals with hospital GPO

EU widens approval for Ventripoint's heart imaging platform

Illumina, Chinese firm forge molecular Dx collaboration

Prosthetic advancements could help Boston bombing victims

GE's MR therapy planning suite gains 510(k) clearance

FDA official touts improved medtech approval process

Defect concerns prompt recall of Covidien's ventilator batteries

6th Annual FDA/MTLI Medical Devices and IVD Statistical Issues Workshop

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Nobody can go back and start a new beginning, but anyone can start today and make a new ending.

Abbott wins FDA nod for device to treat cataract patients

MC10 stretches Series C financing round to $18M

LifeCell taps Kinetic Concepts CEO as interim head

Report: Worldwide X-ray market could reach $9.8B in 5 years

Medtech product approvals drop in Australia

Canadian researchers win funds to develop glioblastoma Dx test

Soft-tissue fixation device from MedShape gets FDA OK

Cook Medical releases device used in embolization procedures

Treasury chief hints at flexibility on device tax

FDA OKs tissue-sealing shears from Microline

Design and Analysis Challenges for Pediatrics and Rare Diseases

6th Annual FDA/MTLI Medical Devices and IVD Statistical Issues Workshop

When in doubt, make a fool of yourself. There is a microscopically thin line between being brilliantly creative and acting like the most gigantic idiot on earth.

CAS Medical's next-gen tissue oximeter gains 510(k) clearance

St. Jude Medical eyes improved pacemaker sales this year

Planmed forges CT distribution deal with Merry X-Ray

Quest appoints new senior VP, acquires clinical-outreach service

European Parliament does not call for premarket review of IVDs

Treating sinusitis: A conversation with Entellus Medical CEO Brian Farley

Army taps Vermillion for ovarian cancer Dx study

Doctor conducts robot-assisted extrapleural pneumonectomies

Next-gen injection system from Carticept wins FDA nod

FDA widens approval for Endologix's aneurysm repair device

Helping medical technology professionals keep pace with regulatory and compliance issues

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To dare is to lose one's footing momentarily. To not dare is to lose oneself.

Aptus clears EU hurdle for next-gen aortic aneurysm device

DySIS Medical gets $11.3M boost for cancer Dx systems

Firms ally to integrate vascular surgery technologies

Former SeraCare exec joins Aushon BioSystems as CEO

Eucomed

Report outlines proposed changes to EU medtech regulation

Finnish firm acquires Euroclone's gastrointestinal Dx unit

Ariz. firm raises funds for study of breast cancer Dx test

IDEO brace helps Green Beret regain use of his injured leg

Samsung's mobile ultrasound device makes U.S. debut

FDA clears Echosens' liver diagnostic device

BioFire seeks FDA clearance for blood culture ID system

Design and Analysis Challenges for Pediatrics and Rare Diseases

6th Annual FDA/MTLI Medical Devices and IVD Statistical Issues Workshop

Besides the noble art of getting things done, there is the noble art of leaving things undone. The wisdom of life consists in the elimination of non-essentials.

Thermo Fisher boosts sequencing business with $13.6B Life Tech buy

Boston Scientific introduces suturing device acquired from Anulex

Lantheus appoints commercial officer, reshuffles other execs

Medtronic confirms layoff plan for its spinal devices business

EndoStim expands distribution of acid reflux device in India

Companies merge to form molecular diagnostics firm

Device keeps Parkinson's patients from halting as they walk

Boston Scientific's MRI pacing system implanted in first trial patient

DVD player finds second life as blood-scanning microscope

Luminex gets FDA nod for device used to detect gastroenteritis

Medical Device Complaints, MDRs and Reports

Molecular Diagnostics

Be of love (a little) more careful than of anything.

Boston Scientific gets FDA OK for device to treat chronic pain

Covidien strikes lung technology distribution deal with VIDA

Biodesix raises $8.8M, enters Dx partnership with Bruker

Salvatore Emma Jr. takes the helm of Arrhythmia Research

Brazil takes steps to expedite product-registration submissions

Cook Medical initiates study of venous self-expanding stent

Quest to use Matrix-Bio-developed biomarkers for breast cancer test

Anesthesia mask from Teleflex lands 510(k) clearance

Convergence of U.S., EU medtech rules urged at forum

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EOS Imaging gains FDA nod for updated spine imaging software

Design and Analysis Challenges for Pediatrics and Rare Diseases

6th Annual FDA/MTLI Medical Devices and IVD Statistical Issues Workshop

It has ever been my experience that folks who have no vices have very few virtues.

Maquet's catheter device gains 510(k) clearance

Colo. firm raises $1.1M for bladder measurement device

Women's health device firm lands $1.1M investment

Robert Hureau to join Kinetic Concepts as CFO in May

Japan approves Kinetic Concepts' portable wound healing device

MHRA says EU medical device rules are unclear on software

Pivotal trial begins for Medtronic's neurostimulation device

Smart prosthetic hand from Touch Bionics is released

FDA would get $821M boost under HHS budget proposal for 2014

FDA clears radiotherapy system from Elekta

Molecular Diagnostics

Helping medical technology professionals keep pace with regulatory and compliance issues

When a true genius appears in the world, you may know him by this sign, that the dunces are all in confederacy against him.

Olympus gets FDA OK for device used in laparoscopic surgery

Calif. maker of cardiac monitor obtains $15.1M

Funding round pulls in $6M for Calif. device startup

Ariz. concussion Dx firm raises about $2.2M in financing

CEO of Uroplasty leaves post

EU approves St. Jude Medical's devices to treat dystonia

Biomet CEO (and blogger) Jeff Binder takes a strong stand on gain-sharing

Diabetes research gets closer to devices that mimic a pancreas

Medtronic releases device used in cardiac lead implantation

FDA seeks comments on combined-function molecular Dx proposal

FDA panel meeting on orthopedic devices rescheduled for May

Medical Device Complaints, MDRs and Reports

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To live is so startling it leaves little time for anything else.

Allied submits 510(k) application for heart tissue device

Mass. startup gets $5M boost to market automated suture device

Former Alphatec Spine exec takes the helm of IlluminOss

Eucomed

Spain remains heavily in debt to medtech sector

Bausch + Lomb's laser device gains CE mark for corneal incisions

French firm wins funds for work on HIV/AIDS, obesity

ResolutionMD for Android receives FDA clearance

Full-field digital mammo device from Fujifilm introduced

Proposal to repeal device tax gets enough support to clear House

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FDA seeks input on effects of extreme weather on medtech

Navigating the SEC's New Conflict Minerals Disclosure Requirements

Join the AdvaMed-MTLI LinkedIn group!

Before you visit the exhibit hall at an annual conference or scientific session, how much planning do you do?

Our political institutions work remarkably well. They are designed to clang against each other. The noise is democracy at work.

Bausch + Lomb wins FDA panel vote for eye implant

N.Y. ultrasound device firm lands $1.3M investment in Conn.

Cytomedix gets funding support from Maryland Venture Fund

Neusoft strikes CT marketing deal with Block Imaging

Former Dentsply executive joins Stryker as CFO

Investment group to pump money into UK health care firms

New lab-on-a-chip diagnostic tool processes blood faster

MRI-guided laser ablation device from Monteris wins FDA nod

U.S. needs market-driven regulatory framework, von Eschenbach says

FDA to host public workshop on women's health devices

Design and Analysis Challenges for Pediatrics and Rare Diseases

6th Annual FDA/MTLI Medical Devices and IVD Statistical Issues Workshop

Saints are sinners who kept on going.

Medtech employees earn more than counterparts in other sectors

Cheetah Medical raises $14.5M in funding round

N.J. cancer Dx firm looks to obtain $6M from IPO

Calif. artery device firm gains $6M in equity financing

Hologic clears regulatory hurdle in Canada for 2 HPV assays

Mass. diagnostics company to set up shop in Scotland

InVivo gets FDA OK to test bioscaffold in acute SCI patients

MRI-based catheter holds promise for vascular surgery

U.S. economy, patients are threatened by medical device tax

FDA delays meeting on shortwave diathermy device proposal

Navigating the SEC's New Conflict Minerals Disclosure Requirements

Helping medical technology professionals keep pace with regulatory and compliance issues

If we would guide by the light of reason, we must let our minds be bold.

CryoLife's next-gen hemodialysis device gains 510(k) clearance

ProUroCare Medical hopes to raise $2.5M in financing

Cardiac Dimensions obtains $2.37M in funding round

Volcano reorganizes top tier

Medtronic gets CE mark for heart stent introducer sheath

London IPO pulls in $12.1M for U.S. neurodiagnostics firm

Symetis' second-gen TAVI device shows positive trial results

Elekta releases multisession radiosurgery device in Japan

FDA to hold meeting on global cardiovascular registry consortium

FDA grants HUD status to InVivo's bioscaffold

Medical Device Complaints, MDRs and Reports

Molecular Diagnostics

I believe in getting into hot water; it keeps you clean.

Smith & Nephew moves to boost presence in emerging markets

Funding round pulls in $3.5M for Renovis Surgical

Calif. cardiovascular-device startup lands $2.5M investment

Minnetronix appoints former SurModics exec as CFO

William Demant pays $73.9M for French cochlear-implant maker

French ultrasound-device firm obtains $36M

Venture capital: Third Rock Ventures' new $516M fund, investment manifesto and recipe for success

Doctors create prosthetic face with help from 3-D printer

128-slice CT scanner from Hitachi gets FDA OK

FDA aims to give reviewers an inside view of medtech development

FDA expands clearance for Lensar's cataract laser device

Navigating the SEC's New Conflict Minerals Disclosure Requirements

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Action is a great restorer and builder of confidence. Inaction is not only the result, but the cause, of fear.

Medtronic gains 510(k) clearance for blood oxygenator

Report: Medtech saw biggest growth in patent activity in 2012

Toshiba's internal merger is finalized

Eucomed

Apollo gets CE mark for endoscopic suturing device

NICE rebrands, appoints new chairman

Trial begins for Seventh Sense's blood collection system

Device for people with situational hearing problems is available

Gamma knife system is deployed at Fla. hospital

FDA outlines user fee protocols for medical device applications

AdvaMed asks for clarity on medical device tax rules

Design and Analysis Challenges for Pediatrics and Rare Diseases

6th Annual FDA/MTLI Medical Devices and IVD Statistical Issues Workshop

Hold on; hold fast; hold out. Patience is genius.

Cardiac Science offloads diagnostic cardiology business

Wis. maker of asthma sensor obtains $6.9M in funding round

Former Siemens exec named marketing VP of Toshiba

Chinese health care market expected to hit $1 trillion by 2020

Report predicts rapid growth for global injectable drug market

Trial begins for Abiomed's right-side heart pump

Mass spectrometry method has promise in diagnosing pancreatic cancer

Welch Allyn unveils single-use blood pressure cuff

Appeals court rules in favor of Abbott in patent suit

Navigating the SEC's New Conflict Minerals Disclosure Requirements

Join the AdvaMed-MTLI LinkedIn group!

That which grows fast, withers as rapidly. That which grows slowly, endures.

Consort eyes investments in Dx, drug-handling firms

Harvard to spin off regenerative medicine unit after IPO

Life Technologies to invest $18M for Calif. facility expansion

Funding round brings in $3M for SafeStitch Medical

Sequoia to develop neonatal Dx test with Russian academy

Kips Bay gets FDA OK to expand eSVS Mesh device study

Device designed to automate dosing, delivery of asthma meds

SonoSite releases needle-guidance tool for ultrasound devices

Lawmakers respond to editorial criticizing device-tax repeal

Federal court awards $176.5M to Covidien in patent suit

Design and Analysis Challenges for Pediatrics and Rare Diseases

6th Annual FDA/MTLI Medical Devices and IVD Statistical Issues Workshop

Dreams have only one owner at a time. That's why dreamers are lonely.

T2 Biosystems pulls in $40M in Series E funding round

Atossa enters $30M stock purchase deal with Aspire

Investors pump $1.1M into OrthoData

Doctor named VP of medical affairs at Varian Medical

Toshiba strikes low-dose CT brain angiogram research deal in U.K.

Prosthetic arm socket designer focuses on fit and comfort

Latest tabletop CR reader from Fuji is released

Philips' interventional imaging tool makes Australian debut

FDA urged to use caution over proposed tougher AED oversight

FDA labels Vascular's hemostasis valve recall as Class I

Navigating the SEC's New Conflict Minerals Disclosure Requirements

See AdvaMed-MTLI's schedule of courses

It is impossible to live pleasurably without living prudently, and honorably, and justly; or to live prudently, and honorably, and justly, without living pleasurably.

Medtech sector saw biggest gains in M&A value in 2012, report says

Md. respiratory device firm obtains $26.4M in financing

GeneNews ties Q4 revenue growth to colorectal cancer test

Report: Worldwide biopsy device market could hit $2.1B in 5 years

Russian health care regulatory agency gets new leader

Bill Walton on how medical technology got him back in the game

Mass. Dx firm raises funds to further develop autism test

GE introduces 2 FDA-cleared MR scanners

Push for device tax repeal will gain Obama's vote, Franken says

Device tax repeal efforts receive applause from Medtronic:

PSivida plans to resubmit NDA for Illuvien drug-device combo

Helping medical technology professionals keep pace with regulatory and compliance issues

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We owe something to extravagance, for thrift and adventure seldom go hand in hand.

Cantel announces purchase of Siemens' hemodialysis unit

Bausch & Lomb hopes to raise about $100M from IPO

Minn. maker of surgical fluid disposal device gets $500K boost

Eucomed

Biotronik gets CE mark for MRI-safe heart defibrillators

Genalyte prepares for EU launch of protein evaluation device

Pentagon backs development of blood-cleansing system

Medical and industrial uses feed growth of exoskeletons

Toshiba makes first installation of CT scanner in S.C.

Device-tax repeal will keep U.S. edge in global medtech, exec says

FDA approves third phase of BioControl's heart device study

Medical Device Complaints, MDRs and Reports

Molecular Diagnostics

To know oneself, one should assert oneself.

Argon to pay $362.5M for Angiotech's interventional biz

Immucor finalizes acquisition of Hologic's Lifecodes

Mo. acid reflux device firm raises $11.2M

Ohio maker of laparoscopic sheath obtains $9M

EU approves Sooft italia's eye-therapy delivery system

Japan OKs Stereotaxis' navigation tool for cardiac ablations

Asuragen gets $7.5M to develop molecular Dx assays

Zenalux introduces preclinical tissue analyzer

N.Y. hospital adopts Matakina's breast density app

FDA proposes tougher oversight of external defibrillators

Design and Analysis Challenges for Pediatrics and Rare Diseases

6th Annual FDA/MTLI Medical Devices and IVD Statistical Issues Workshop

It is often laziness and timidity that keep us within our duty while virtue gets all the credit.

Covidien to repurchase $3B more in company shares

Medrobotics obtains $10M in debt financing

Former Claro Scientific executive takes the helm of Vermillion

Egypt updates medical device registration requirements

Brazil's state hemodialysis services get additional $56M this year

ITraumaCar gains EU approval for bleeding control device

Firm works on neurostimulation device to treat bladder disorders

ICAD's brachytherapy system wins FDA nod

Lawmakers pitch advisory panel to review FDA's performance

Navigating the SEC's New Conflict Minerals Disclosure Requirements

Helping medical technology professionals keep pace with regulatory and compliance issues

A thing is mighty big when time and distance cannot shrink it.

Senate passes budget amendment to repeal device tax

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Cardiovascular Systems targets $33M from stock sale

Mass. blood collection device firm obtains $1.9M

Chinese regulators approve ETView's pulmonary device

Brazil considers new role for pharma, med tech to avoid disruptions

Sorin's heart device study gains FDA approval

X-spine's sacroiliac joint fusion device wins FDA nod

Tenn. facility adopts Konica's wireless DR panels

J&J unit gets FDA OK for cordless surgical tissue sealer

FDA won't subject smartphones to device tax, official says

Medical Device Complaints, MDRs and Reports

Molecular Diagnostics

If we were all given by magic the power to read each other's thoughts, I suppose the first effect would be to dissolve all friendships.

Abbott wins FDA panel vote for mitral valve repair system

SynCardia raises $19M for global product expansion

N.C. atrial fibrillation device firm seeks to obtain $13M

Heart Dx firm receives $450K in tax incentives in Mass.

Spanish diabetes guidelines stress value of neonatal, genetic tests

What's going on in orthopedics? A chat with Jeff Binder

Researchers develop point-of-care HIV test

Quantel's laser-based eye treatment device gets FDA OK

Toshiba makes first U.S. installation of multislice CT scanner

Senators propose budget amendment to address device tax repeal

Prompt release of FDA guidance on mHealth urged at hearing

Design and Analysis Challenges for Pediatrics and Rare Diseases

6th Annual FDA/MTLI Medical Devices and IVD Statistical Issues Workshop

A community is like a ship; everyone ought to be prepared to take the helm.

Bipartisan support key in repealing device tax

Calif. heart device startup closes $25M financing round

Arup signs marketing deal with Natera for prenatal assay

Eucomed

Welsh government opens $159M fund for life sciences firms

UK molecular Dx firm gets $1.1M boost to expand tech sales

Engineer uses 3D printing technology to improve prostheses

Dune Medical's breast cancer device debuts in U.S.

EOS gains 510(k) clearance for advanced 3D imaging technology

Meridian earns CLIA moderate complexity rating for Strep tests

NuVasive gets warning letter over spinal implant marketing

Navigating the SEC's New Conflict Minerals Disclosure Requirements

See AdvaMed-MTLI's schedule of courses

Quality is not an act, it is a habit.

FDA OKs 2 HUD designations for artificial heart from SynCardia

Mass. heart device company lands $10.7M investment

President of Zimmer's global business leaves post

Accuray's radiotherapy devices are adopted in Hong Kong

Brazilian regulator OKs Faxitron's digital radiography devices

Mass. research center for saliva-based tests gets $4.1M boost

3D ear scanner from Lantos scores FDA clearance

Salivary duct access devices from Cook Medical are available

Proposed budget hike would increase FDA oversight in China

Quidel's C. difficile test gets FDA OK for Life's Dx platforms

Helping medical technology professionals keep pace with regulatory and compliance issues

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You may have to fight a battle more than once to win it.

InspireMD's device to prevent blood clots lands EU approval

New York Imaging continues acquisition trail with GXC Imaging

BioClinica to merge with CoreLab Partners

U.S. subsidiary of Bracco Imaging gets new CEO

Canada issues final rules on classifying products as drugs, devices

Device to preserve livers for transplant is used successfully in U.K.

Siemens debuts 2 ultrasound devices at cardiology meeting

Hospital GPO taps GE for infant care technologies

FDA warns Hospira over problems at N.C. plant

Molecular Diagnostics

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What men value in this world is not rights but privileges.

VertiFlex sells noncore spinal technology to Stryker

Calif. diabetes monitoring device firm hopes to raise $1.7M

Nexxt Spine's relocation plan could add 44 jobs in Ind.

Israeli maker of acid reflux device lands $8M investment

Pathwork moves to bring cancer diagnostic test to China

Firms team up to develop companion Dx for solid tumor drugs

Siemens introduces fully digital 2-in-1 imaging device

U.S. first-to-file patent rules take effect Saturday

CEO of Merit Medical weighs in on first-to-file patent scheme:

FDA warns Fresenius over dialyzer validation issues at Utah plant

Medical Device Complaints, MDRs and Reports

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Adventure is not outside man; it is within.

RTI wins FDA nod for device used in soft tissue repair

Heart test sales fuel Q4 revenue growth for BG Medicine

Atossa agrees to supply breast cancer tests to FedMed

UMRi to distribute Danish firm's gamma camera in the U.S.

EU approves Nanosphere's gram-negative blood assay

Singapore cancer Dx firm obtains $7.2M in funding round

Does the FDA need an NTSB?

Firm gains about $13M for glaucoma ultrasound device trial

3 hernia repair devices from Covidien debut at Fla. event

FDA regulation of mHealth apps to be subject of hearings

Optos gets FDA OK to add microperimetry to OCT SLO device

Design and Analysis Challenges for Pediatrics and Rare Diseases

6th Annual FDA/MTLI Medical Devices and IVD Statistical Issues Workshop

Success is a lousy teacher. It seduces smart people into thinking they can't lose.

Alphatec scores 510(k) clearance for spinal fusion system

J&J unit wraps up Flexible Stenting Solutions acquisition

Calif. molecular Dx firm posts revenue growth in Q4

Covidien CEO: How to make crucial decisions

Eucomed

Cohera advances surgical sealant to human trials in Europe

Pivotal phase of St. Jude's stroke device trial begins

Surgionix to launch orthopedic device at Chicago event

IPhone-based ECG device gets FDA OK for nonprescription use

FDA finalizes guidance on clinical researchers' financial disclosures

FDA gives Quidel nod on molecular respiratory viral test

Helping medical technology professionals keep pace with regulatory and compliance issues

Navigating the SEC's New Conflict Minerals Disclosure Requirements

Humor is an affirmation of dignity, a declaration of man's superiority to all that befalls him.

Invendo gets FDA OK for single-use colonoscopy device

Abiomed's heart pump wins expanded coverage from 4 insurers

Industry veteran joins CIVCO as North American sales VP

U.K. regulatory agency unveils Innovation Office

GI Dynamics taps CMS Medical to market EndoBarrier in Brazil

BiO2 reports first use of pulmonary embolism device in Europe

Screening tool boosts survival rate of children with ALL

St. Jude releases device to promote personalized stenting

New MRI scanner from Philips allows imaging of more patients

InVivo resubmits IDE application for spinal cord injury device

Molecular Diagnostics

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We are all worms. But I do believe that I am a glow-worm.

Merit's microspheres for enlarged prostate win EU approval

Ampio Dx unit eyes $5M for device to measure oxidative stress

Sekisui to expand clinical Dx business with relocation plan

Worldwide market for GI devices could hit $33.3B in 10 years

Deal brings majority stake in Progenika to Grifols

Study: Edwards' Sapien XT heart valve is comparable to older model

Army awards $2.5M for work on TBI screening device

Cardiac ultrasound devices from Toshiba debut at Calif. event

FDA critic calls for independent post-market device, drug oversight

Boston Scientific addresses concerns over lead-free defibrillators

Medical Device Tax Workshop

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The greatest way to live with honor in this world is to be what we pretend to be.

Siemens Healthcare scores FDA win for angiography devices

Wright Medical wraps up acquisition of BioMimetic

Calif. pain relief device firm obtains $48M in funding round

Lantheus names industry veteran Orlandi to be CMO

Bioinformatics, cancer Dx projects in Spain get $1.3M boost

NICE backs Sysmex's breast cancer sentinel node testing tool

CircuLite gains FDA approval for blood pump study

Vital Images' TAVR planning app lands 510(k) clearance

FDA issues new rules on pulse oximeter 510(k) submissions

Edwards asks FDA to extend patent for Sapien heart valve

Medical Device Complaints, MDRs and Reports

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Hope never abandons you, you abandon it.

Medtronic obtains approval for cardiac leads in Europe

MxBiodevices seeks $8 million for diabetic foot ulcer study

4 medtech firms land supply contracts from hospital GPO

CEO of Stereotaxis leaves post

Oxford unit wins S. Korean approval for refurbished CT, MRI devices

Mobile oncology application from ONCOassist gets CE mark

When it comes to robots, opinions run hot

Method could prevent GVHD in bone marrow transplants

Barco debuts 22-inch monitors for clinical image viewing

FDA offers guidance on financial disclosures under Sunshine Act

Roche gets FDA OK for advanced hepatitis C viral load assay

Design and Analysis Challenges for Pediatrics and Rare Diseases

6th Annual FDA/MTLI Medical Devices and IVD Statistical Issues Workshop

Scientific progress makes moral progress a necessity; for if man's power is increased, the checks that restrain him from abusing it must be strengthened.

Philips gets FDA OK for cardiac image-guidance system

Swallow Solutions raises about $1M for dysphagia systems

Harvard licenses stem cell assays to Life Technologies

Eucomed

Medtronic gains expanded EU approval for drug-eluting stent

EU approves Bolton Medical's abdominal stent graft

DFine touts ablation system's performance in imaging study

AccuVein unveils new version of vein illumination device

Self-retaining surgical ratchet from Symmetry is launched

House panel holds hearing on medical device tax repeal

House Republicans ask FDA to clarify proposed mHealth regulations

Navigating the SEC's New Conflict Minerals Disclosure Requirements

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Every time you spend money, you're casting a vote for the kind of world you want.

TranS1 boosts spinal device portfolio with Baxano buy

25 life sciences firms receive $25M in tax incentives in Mass.

EnteroMedics raises about $12 million for obesity device

Analogic wraps up Ultrasonix Medical acquisition

EKF moves to make inroads in molecular Dx market

Brazil to allow foreign inspection of medtech import licensees

Trial begins for Endologix's aortic aneurysm device

Aesculap's device to treat hydrocephalus is available

FDA OKs Bluetooth-enabled blood glucose monitor from LifeScan

Risk of brain damage prompts recall of Ad-Tech's subdural electrodes

Helping medical technology professionals keep pace with regulatory and compliance issues

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Concentrate all your thoughts upon the work at hand. The sun's rays do not burn until brought to a focus.

Mercator gains EU approval for micro-infusion catheters

QuantuMDx announces acquisition of ID testing company

Alere receives $42.2M boost from Gates Foundation

NeoGenomics hopes to raise $7.8 million from stock sale

Global MRI market could hit $6B in five years, report says

Strong growth is expected for Nigerian laboratory test market

Trial compares heart implant, warfarin for AF patients

Advanced tumor-targeting device from Elekta is released

AdvaMed CEO raises concerns over fallout from sequestration

FDA examines complications tied to Intuitive's surgical robot

Medical Device Tax Workshop

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The man who insists upon seeing with perfect clearness before he decides, never decides. Accept life, and you must accept regret.

Medtronic clears EU hurdle for catheter-based heart valve

Calif. heart device firm completes $48 million funding round

Mass. insulin pump maker expects up to 21% revenue growth this year

Digirad plans to move headquarters to Atlanta

Israeli regulator approves GI Dynamics' EndoBarrier system

U.K. regulatory agency seeks new chief executive

Amputee receives groundbreaking implant for prosthetic arm

Full-field digital mammo device from Philips gets FDA OK

Medtech companies strike supply deals with hospital GPO

FDA clears hip fixation implant from ArthroCare

Helping medical technology professionals keep pace with regulatory and compliance issues

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Mediocrity knows nothing higher than itself, but talent instantly recognizes genius.

Bausch + Lomb wins FDA date for vision-correcting implant

PLC raises $4 million to further develop RenalGuard system

Natera signs deal with Bio-Reference for prenatal test

Biocartis wins $2.5M to develop cancer assays

EU approves single-needle technology from NxStage

EU holds first debate on proposed new medtech regulations

JNJ, Medtronic top list of best medical device companies to work for

ReShape wraps up enrollment in weight-loss device study

Diabetes management software from Tandem gets FDA OK

Momentum builds in the fight against 2.3% device tax

FDA OKs device to train surgeons in spine procedures

Medical Device Tax Workshop

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He that will not apply new remedies must expect new evils; for time is the greatest innovator.

AdvaMed works to shield FDA user fees from budget sequestration

Carestream Health may be mulling sale

Signostics taps Konica to distribute 2nd-gen ultrasound device

Bio-Rad's biotech, clinical Dx segments post Q4 revenue growth

Eucomed

Respiratory assist device from ALung gains EU approval

Early study of Medtronic's pulmonary valve gets FDA OK

Radiologist develops nonreusable syringe

Prosthetic heart valve from On-X Life wins FDA nod

Lawmaker calls for help in push for device tax repeal

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FDA plan would revise rules on device trials outside U.S.

Premarket Approval (PMA) Submissions Workshop

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If you want to truly understand something, try to change it.

Biotronik wins FDA nod for single-lead, atrial-sensing ICD

Medtronic again joins funding round for Intersect ENT

Tornier names new CEO, reports sales and revenue growth

NxStage scores another EU win for hemodialysis system

Medtech innovation soars in Brazil thanks to Conitec

Collaborative effort could advance development of early RA test

Additional sizes of Medtronic's heart stent get FDA OK

Analog releases 8-channel receiver for ultrasound systems

Medical plastics producers see applications in O&P

FDA guidance aims to clarify device enhancements, recalls

Investigational Device Exemption (IDE) Submissions Workshop

Premarket Approval (PMA) Submissions Workshop

Shared joys make a friend, not shared sufferings.

Quest to divest HemoCue diagnostic biz for about $300 million

Illumina wraps up $450M buyout of Verinata Health

Masimo reports sales growth during fourth quarter

ResMed promotes Americas operations president to CEO

Argentina enacts updated medical device regulations

Dako strikes supply deal with S. Korean biotech firm

Blaze Bioscience raises $8.5M for tumor imaging technology

Shimadzu to debut radiography/fluoroscopy device at conference

NeuroPace wins FDA panel vote for epilepsy system

Analysis finds improvement in FDA's 510(k) review process

Medical Device Reimbursement Workshop

Investigational Device Exemption (IDE) Submissions Workshop

It is wonderful how much news there is when people write every other day; if they wait for a month, there is nothing that seems worth telling.

Survey: Medtech firms could cut jobs, R&D to manage device tax

Gynesonics raises $21M for device to treat uterine fibroids

Mass. diagnostics company gets $2M boost for autism assay

Nuclea obtains $1 million in equity funding round

Malaysia accepts registration requests from device assessment bodies

Covidien wraps up patient enrollment for iliac stent trials

Abbott will develop assay for Janssen-Pharmacyclics leukemia drug

Diagnovus launches tumor tissue test for non-Hodgkin lymphoma

Bill introduced to shield emergency medtech from 2.3% device tax

FDA panel review for NeuroPace's epilepsy device slated today

510(k) Submissions Workshop

Investigational Device Exemption (IDE) Submissions Workshop

You can do anything in this world if you are prepared to take the consequences.

Sorin makes inroads in Brazil with Alcard acquisition

Cytomedix targets up to $27.5M with 2013 financing plan

Ovarian cancer test helps boost Q4 revenues for Vermillion

Bonesupport's antibiotic-eluting bone substitute gets CE mark

Boston Scientific CFO: "The portfolio is there. Now it's all about execution."

U.K.'s first hand transplant recipient gains sensation

Sanitas' outpatient management system gets FDA OK

Spinal fixation device from ulrich medical debuts in U.S.

GE Healthcare hits milestone for SPECT/CT system

FDA proposal would require pediatric data in submissions

Senator to consult industry on pay-for to advance device tax repeal

510(k) Submissions Workshop

Investigational Device Exemption (IDE) Submissions Workshop

Never help a child with a task at which he feels he can succeed.

NxStage gains wider EU approval for hemodialysis system

Molecular Dx startup wins about $977K from Canadian government

Diabetes joint venture picks former Medtronic exec as CTO

Eucomed

EU panel to begin debate on proposed medtech rules next month

EU OKs Dune's next-gen breast cancer tissue assessment device

Neuroprosthetic therapies may enable spinal injury patients to walk

Breakthrough prosthetic hand will have the ability to feel

Hospital GPO awards supply contract to Philips

FDA issues draft guidance on third-party device review program

FDA approves essential tremor study using InSightec's device

Helping medical technology professionals keep pace with regulatory and compliance issues

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We must travel in the direction of our fear.

Oxford wins FDA nod for patient-specific cranial system

More than 9,000 medtech employees sign petition for device tax repeal

Transmedic gains distribution rights to Saladax's oncology tests

EU approves MRI-safe defibrillators from Biotronik

Revenues for Australian medtech sector hit $12B in 2012

St. Jude tests expanded use for renal denervation device

Applied Spectral's automated gene scanner wins FDA approval

Complete Medical signs distribution deal with GE

FDA sets review date for Abbott's aortic valve repair system

Exact advances PMA application for colorectal cancer test

Medical Device Tax Workshop

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Everything that lives, lives not alone, nor for itself.

Lombard Medical gets FDA OK for aneurysm device

Boston Scientific takes part in $27M funding round for BaroNova

Pa. company obtains $17 million for surgical adhesive

Professional Dx segment boosts Q4 revenues for Alere

EU regulators approve ApiFix's scoliosis correction device

Postmarket trial begins for ReCor's hypertension device

Fujifilm Medical adds cassette tray option for DR system

Medtech boot camp for military veterans kicks off

FDA gives Dako nod on rapid cancer diagnostic test

FDA clearance sought for Affymetrix's cytogenetics platform

Medical Device Reimbursement Workshop

Premarket Approval (PMA) Submissions Workshop

You will become as small as your controlling desire; as great as your dominant aspiration.