Tuesday, May 28, 2013

Heart device approval delays leave U.S. doctors frustrated

Combination photo shows the original Edwards Lifesciences Sapien replacement heart valve and the second generation Sapien XTBy Bill Berkrot NEW YORK (Reuters) - Americans accustomed to immediate access to the newest technology may be shocked to find that is not the case when it comes to devices that treat ailing hearts. U.S. approval requirements for cardiac devices are much more stringent than in Europe, where there is no centralized decision-making body. But a growing number of U.S. heart doctors feel the regulations are so demanding that patients are being denied access to beneficial therapies. ...


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