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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Dec. 13, 2013

View Archived Issues

FDA Advisory Committee: Watchman wins at advisory, but post-approval issues lurk

GAITHERSBURG, Maryland — Boston Scientific (BSX; Natick, Massachusetts) scored a resounding 13-1 victory in the second advisory panel for the Watchman left atrial appendage closure device in a hearing that drew 10 respondents for the open public hearing. The vote came with a strong recommendation for a heftier post-approval study recommendation than the firm had proposed, which was a single-arm, five-year study of 1,000 existing and new patients. The big question is whether the company will have to foot the bill for a post-approval study and participate in the build-out of a registry. Read More

Cook initiates its study for Evolution Esophageal stent

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Report from Europe: St. Jude's 25 mm Portico valve approved in Europe for TAVR

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New residency program requirementscreate opportunities for companies

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Financings roundup: Avinger reports completion of 'signifcant' new financing round

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Agreements/contracts: Tissue Regenix to distribute dCELL in new U.S. markets

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Deals roundup: Centene acquires majority Interest in U.S. Medical Management

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Grants roundup: ZetrOZ gets NIH support for osteoarthritis study

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People in Places

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Product briefs

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MDD's Diagnostics Extra

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