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Sanovas CEO Larry Gerrans and the MicroCam technology
Sanovas CEO Gerrans goes linear with new MicroCam

Sanovas' new MicroCam plug-and-play endoscopic imaging system paves the way for a paradigm shift toward linear medical devices for natural orifice surgery, CEO Larry Gerrans tells MassDevice.com.

Data and Healthcare
Podcast: Healthcare giants unite to turn Big Data into medtech savings

A quartet of healthcare giants including UnitedHealth, the largest single health insurer in the U.S., joins forces for the SharedClarity project, aiming to leverage their combined Big Data to get the best devices for the best prices.
The E-bay of medical devices: A conversation with Aptitude's Troy Kirchenbauer
Building the E-bay of medical devices: A conversation with Aptitude's Troy Kirchenbauer

MassDevice talks disruptive business models in the medical device and hospital world with Novation executive and aptitude vice president Troy Kirchenbauer
Emergency Preparedness Checklist
FDA advisors look to Hurricane Katrina, Japanese tsunami for lessons in protecting medtech systems

Although current quality systems are likely sufficient, the FDA should look to lessons learned from recent catastrophes in developing risk mitigation strategies to better protect medical devices and related systems, an agency panel says.
Biomet CEO (and blogger) Jeff Binder takes a strong stand on gain-sharing
Biomet CEO (and blogger) Jeff Binder takes a strong stand on gain-sharing

Biomet CEO Jeff Binder tells MassDevice.com why gain sharing is bad for the medical device business and how the best is yet to come for the orthopedics sector.

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Medical device sales: Wright Medical's pilot program on rep-less sales process worth watching
Medical device tax: How much are companies paying to government for healthcare reform?
Boston Scientific may finally be on the right path again
St. Jude Medical kicks off renal denervation device study
Medical device M&A: Activity still strong despite Q1 declines in deal value, volume

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FDA Inspection Trends
The FDA is implementing several new initiatives to maintain better oversight of contract research organizations conducting clinical trials. This paper looks at

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Stanford researchers make wearable heart monitor that's thinner than a dollar bill
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Can Johnson & Johnson fire on all cylinders again?

May 20, 2013 by MassDevice

Shares of Johnson & Johnson are up 40% over the past year, but the rally hasn't accompanied strong, even financial performance, especially from its struggling medical device segment.

Can Johnson & Johnson fire on all cylinders again?

By Stephen Simpson

News Well, Wall Street Beat

MassDevice.com +3 | The top 3 med-tech stories for May 20, 2013

May 20, 2013 by Arezu Sarvestani

If you read nothing else today, make sure you're still in the know with MassDevice +3.

Plus 3

Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This feature of MassDevice.com's coverage highlights our 3 biggest and most influential stories from the day's news to make sure you're up to date on the headlines that continue to shape the medical device industry.

 

News Well, Plus 3

Weight loss: GI Dynamics' U.S. clinical trial taxes its coffers

May 20, 2013 by Arezu Sarvestani

Weight-loss devices maker GI Dynamics tells investors today that the company may seek new funding as it works to support clinical trials in pursuit of U.S. regulatory approval.

GI Dynamics logo

Investors Down Under shied away from weight-loss devices maker GI Dynamics (ASX:GID) today after president & CEO Stuart Randle told shareholders that the company may need to raise new funds in order to support its clinical trials.

News Well, Clinical Trials, Diabetes, Food & Drug Administration (FDA), Wall Street Beat, Weight loss

ViewRay closes in on $17.4M round

May 20, 2013 by Sony Salzman

Medical device company ViewRay announces a $17.4 million funding round, offering equity and Series D-2 preferred stock.

ViewRay

ViewRay Inc. has $2.4 million to go to reach its goal for a $17.4 million funding round

Seven investors are in on the offering, and $15 million had been sold at the time the company disclosed the funding round May 8, according to a regulatory filing.

News Well, Funding Roundup, Imaging

Diabetes: Abbott's glucose monitor software glitch gets FDA's highest-risk recall

May 20, 2013 by Arezu Sarvestani

The FDA slaps its highest-risk classification on Abbott Labs' FreeStyle InsuLinx blood glucose meter recall.

Abbott Labs logo

The FDA slapped its highest-risk label on Abbott's (NYSE:ABT) blood glucose meter recall, deeming the software glitch potentially deadly for patients.

Abbott last month said that it had already issued a free software update to patch the problem, which may affect as many as 50,000 FreeStyle InsuLinx blood glucose meters on the market.

News Well, Diabetes, Food & Drug Administration (FDA), Recalls, Regulatory/Compliance

Biosensors International wins CE Mark for latest line of drug-eluting stents

May 20, 2013 by Sony Salzman

Biosensors International lands European approval for its BioMatrix NeoFlex drug-eluting stent.

Biosensors

Biosensors International (PINK:BSNRY) said it won a green light from European regulators for its BioMatrix NeoFlex drug-eluting stent, the latest in its DES line.

News Well, Regulatory/Clearance, CE Mark, Stents

Covidien restates Q2 financials ahead of pharma spinout | Wall Street Beat

May 20, 2013 by Brad Perriello

Covidien restates its financial results for its fiscal 2nd quarter ahead of the spinout of its Mallinckrodt pharmaceuticals business, expected next month.

MassDevice.com Wall Street Beat

Covidien (NYSE:COV) re-stated its financial results for the fiscal 3rd quarter ended March 29, in anticipation of the planned spinout of its Mallinckrodt pharmaceuticals business next month.

Covidien said the new numbers reflect the pharma unit as a discontinued operation, with COV shareholders slated to receive a tax-free distribution, according to a regulatory filing.

News Well, MassDevice.com Earnings Roundup, 2013, Q1, Wall Street Beat

U.S. FDA to require proof of IEC 60601-1 3rd Edition in summer 2013

May 20, 2013 by MassDevice

The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.

Global Medicine

By Stewart Eisenhart, Emergo Group

The US Food and Drug Administration will begin requiring manufacturers and sponsors of electrical medical devices to show compliance with the standard ES 60601 3rd Edition starting June 30, 2013.

News Well, Blog, Food & Drug Administration (FDA), Regulatory/Compliance
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