FDA Doubtful On New Watchman Data From Boston Scientific Corporation
Preliminary materials from the FDA on the Watchman anti-stroke device from Boston Scientific (NYSE:BSX) show that the agency has its doubts about whether to allow the cardiac implant onto the U.S. market.
The FDA's Circulatory Devices advisory panel is slated to meet Oct. 8 for an unprecedented 3rd review of clinical trial data for the Watchman device. Despite an initial vote recommending approval, the FDA denied in March 2010 issued a "not approvable" letter to Marlborough, Mass.-based Boston Scientific.
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The FDA's Circulatory Devices advisory panel is slated to meet Oct. 8 for an unprecedented 3rd review of clinical trial data for the Watchman device. Despite an initial vote recommending approval, the FDA denied in March 2010 issued a "not approvable" letter to Marlborough, Mass.-based Boston Scientific.
Help employers find you! Check out all the jobs and post your resume.