According to an August 22nd article in FierceMedicalDevices the FDA has picked up the pace on the most novel medical devices, but this year might not match levels seen in 2011 and 2012. To highlight this point, the article points out the agency granted 17 premarket approvals, which is a marked increase over the 23 granted for the entirety of 2013.
The average review time for PMAs during the first half of 2014 was 18.4 months, compared to 35.9 months in 2013. This was aided by the fast approval in January for Medtronic’s transcatheter aortic value CoreValve that was approved in only 5.8 months. Edwards LifeSciences has a competitive product approved in June.
Nearly two-thirds of the PMA approvals during the first half of 2014 went to big med tech companies. Smaller public and private companies also had some notable approvals, with CardioMems being the most notable to garner a notable FDA approval. St. Jude medical eventually acquired the company.
Do you feel that fast approvals for novel devices will be a continuing trend moving forward? Please share your thoughts below.
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