Monthly Archives: October 2014

3rd FDA Panel Barely Favors BSX’s Watchman

3rd FDA panel vote barely favors Boston Scientific’s Watchman anti-stroke device Medtronic launches Verify incontinence device in the U.S FDA OKs Integra Lifesciences Puerto Rico plant; FDA approves Bard’s Lutonix DEB An FDA advisory panel offered a mixed view of Boston Scientific’s Watchman heart device earlier this month, concluding it is probably safe but not…

FDA Approves Bard’s Lutonix DEB

C.R. Bard ($BCR) won a unanimous vote from an FDA advisory panel for its drug-eluting balloon catheter, setting the stage for the device’s full regulatory approval. The FDA’s Circulatory System Devices Advisory Panel recommended that the company’s Lutonix drug-coated balloon PTA catheter (DCB) be approved in the U.S. to treat peripheral artery disease (PAD) by…