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Clinical Update: A gap in the FDA’s oversight of medical device trials

November 27, 2010 By MassDevice staff Leave a Comment

Clinical trials roundup

There’s a “potentially troubling gap” in the Food & Drug Administration’s oversight of medical device clinical trials, according to the Wall Street Journal — the federal watchdog agency doesn’t inspect device-making plants during trials.

The Journal, citing the failed clinical trial of an Aptus Endosystems Inc. stent graft, said the lack of oversight means “hundreds of participants in clinical-trial studies of medical devices may be at risk of receiving faulty devices.”

Filed Under: Business/Financial News, News Well, Stent Grafts Tagged With: Aptus EndoSystems Inc., Bioabsorbable Stents, Clinical Trials, NxStage Medical Inc., OrbusNeich

California endovascular firms drum up $45 million

August 30, 2010 By MassDevice staff Leave a Comment

Endogastric, Aptus logos

California-based EndoGastric Solutions Inc. and Aptus EndoSystems Inc. brought in $30 million and $15 million, respectively, in separate funding rounds.

Menlo Park, Calif.-based Canaan Partners and New York-based Radius Ventures led EndoGastric’s $30 million Series F round, which was designed to support the company through profitability, according to a press release.

Filed Under: Business/Financial News, Endoscopic, News Well Tagged With: Aptus EndoSystems Inc., endogastricsolutions, Gastrointestinal

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