Heart device approval delays leave US doctors frustrated

Reuters, May 28, 2013

(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. From 2006 to 2011, European regulators approved mid-to-high-risk medical devices, including heart devices, an average of four years ahead of the more conservative U.S. Food and Drug Administration, according to a report last year by Boston Consulting Group.


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