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FDA

Latest Headlines

Latest Headlines

AdvaMed says FDA proposed rule would result in more PMAs, device reclassifications

The device industry is awaiting the finalization of the FDA's rule on medical device classification procedures, and will be combing it for the requested changes from the March 2014 proposed rule. More comments asking for an easing of the regulatory burden may be forthcoming, for the FDA extended the public comment period to Sept. 22, according to a notice in the June 12  Federal Register. 

Whill gets $11M Series A for its Segway of wheelchairs

Personal mobility startup Whill has raised $11 million in a Series A round following a successful stint on Kickstarter. The financing will go to manufacture and expand distribution of its sleek, off-road device.

FDA issues largest one-day recall ever for 233 products

Customed received the most serious recall the FDA hands out--a Class I recall. This recall is the largest across-the-board recall the FDA has ever issued to date, 9 times larger than the previous record holding recall.

FDA clears wireless, vitals monitor patch that transmits to smartphone

The FDA has cleared HealthPatch MD, a small, wireless biosensor patch worn on the chest that can track a number of vital signs and biometric measurements. The sensor connects to a smartphone to relay data to a healthcare provider.

Amazon's meeting with FDA starts the rumor mill turning

Amazon is the latest tech giant to consider expanding into healthcare, but details of the online retailer's plans are sketchy.

Boehringer Ingelheim still being dogged by Ben Venue plant

Boehringer Ingelheim is finding it difficult to get the stink of the troubled Ben Venue Bedford, OH, operations off its shoes. It closed the site last year and sold it last month but is still having to recall products produced there that might be contaminated.

Covidien acquires Sapheon ahead of FDA approval for vein adhesive

The Medtronic-Covidien integration team must be working overtime juggling not only existing products but also those in the deal pipeline. The pair hasn't slowed down at all--between them they have disclosed 5 acquisitions since their own merger announcement in mid-June, three of them this week alone.

ReShape targets U.S. approval as EU study shows major weight loss

ReShape Medical revealed the first postapproval data from the EU for its nonsurgical, balloon-based weight-loss system: 42% of excess weight loss on average with a variance of 23%. But the company cautions that because of the different way the trials are designed, it won't have similar results when it releases pivotal U.S. trial data in November.

NAFTA says FDA was in its rights to ban Apotex plants

It's tough luck for Canada's Apotex in its international slug fest with the FDA. An arbitration panel has tossed its claim that the FDA violated the North American Free Trade Act when it banned products from its plants in Toronto and Quebec from 2009 to 2011.

FDA's 'Most Wanted Fugitives': The agency wants your help finding these bad players

You have heard about the FBI Top 10 Most Wanted list, and of the America's Most Wanted television show, but are you familiar with the FDA's list of Most Wanted Fugitives? Yes, the drug oversight agency has bad players who have fled that it would like to bring to justice. And it would like your help to do that.