Monday, December 8, 2014

Edwards CEO hopes FDA to accelerate approvals of medical devices

By Bill Berkrot NEW YORK (Reuters) - U.S. health regulators appear open to speeding up approvals of medical devices that currently often reach European markets three to five years ahead of being cleared in the United States, the chief executive officer of Edwards Lifesciences said. Such a change could help get the third generation of its Sapien transcatheter aortic heart valve replacement (TAVR) to U.S. clinicians faster than previously expected, Edwards CEO Michael Mussallem told Reuters on Monday following the company's business update for analysts and investors in New York. ...



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