Medical devices have been assessed almost twice as rapidly this year by the U.S. Food and Drug Administration as compared to the same period last year, according to analysis conducted by the Evaluate Group.
The FDA awarded 17 first-time premarket approvals in the first half of 2014, up from nine PMAs granted in the first half of last year. If the trend continues there will be 34 PMAs this year. The swiftest PMA review was for Medtronic's transcatheter aortic valve CoreValve with a turnaround time of just 5.8 months.
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