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Medical Device Industry News

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

Biosensor wins CE Mark for latest line of drug-eluting stents

May 20, 2013 by Sony Salzman

Biosensor 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

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

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

Wall Street 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

Medtronic touts European win for Export Advance aspiration catheter

May 20, 2013 by Arezu Sarvestani

Medical device giant Medtronic announces CE Mark approval in the European Union and imminent commercial launch of its Export Advance thrombus removal system.

Medtronic logo

Medical device industry titan Medtronic (NYSE:MDT) announced today that it won CE Mark approval in the European Union for its latest thrombus removal system, the Export Advance aspiration catheter.

The new device, the latest in the Export family, will hit the shelves "soon" in Europe and other international markets, Medtronic reported.

News Well, Regulatory/Clearance, Cardiovascular, CE Mark

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

Can the FDA keep its user fee promises amid sequester?

May 20, 2013 by Arezu Sarvestani

The millions of dollars in fees that medical device companies pay for FDA review aren't exempt from sequestration, meaning the agency may lack the resources to keep up with promises that it made to the industry in exchange for the funds.

medical funding

The federal sequester is siphoning away part of the funds that the medical device industry is paying for FDA review of new technologies, and that means the agency may not be able to keep all the promises it made in exchange for hiking its user fees.

News Well, Capitol Hill, Regulatory/Clearance, Food & Drug Administration (FDA), MDUFMA
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