Login  /  Register  /  Search

Medical Alley Association serves the individuals and organizations that comprise Minnesota's health industry by influencing policy, fostering connections and providing critical intelligence to improve the quality of health around the world.

Medical Alley Association serves the individuals and organizations that comprise Minnesota's health industry by influencing policy, fostering connections and providing critical intelligence to improve the quality of health around the world.

FDA Approvals Report: Q2 2015

We’ve recently reported on national PMA approval and 510(k) clearance trends for 2010-2014 and now release the Q2 2015 FDA Approvals Report.

242 FDA approvals came from Minnesota in Q2 2015, which includes new technology approvals from Medtronic, Boston Scientific, and Greatbatch Medical. New technology highlights include Medtronic's Model 5071 Lead, Boston Scientific's PROMUS Element Plus, and Greatbatch Medical's Myopore Sutureless Myocardial Pacing Lead. 

Minnesota is in the lead with 38% of all PMA approvals, followed by California, Texas, and New Jersey. Overall, Minnesota remains at the forefront in all categories by claiming 18% of all approved devices in Q2 2015. Of the 242 approved devices from 20 MN companies, 70% came from Medtronic and Boston Scientific.

At the subsector level, Minnesota continues to lead total FDA approvals in Urology with 74%, Cardiology with 44%, Gastroenterology with 29%, and Neurology with 28%.

View the full report

8.3.15_Q2 2015 FDA Approvals Report _CROPPED