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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.

Quarterly Report: Approval Q3 2015

Minnesota continues to be nation's fastest in gaining medtech approval

Minnesota continues to lead the nation in gaining the most FDA medical device approvals the fastest. For the third quarter of 2015, Minnesota companies garnered 32% (162) of all new and supplemental PMAs approved (512), followed by California (129) and OUS (51). Our companies accounted for one of the nine new PMAs approved and led in supplemental PMAs, obtaining 161 of the 503 total approved. Our greatest leadership was in Cardiology and Urology, with 38% and 67% of all approvals, respectively.

Boston Scientific, Medtronic and St. Jude Medical accounted for 21% of all FDA approvals in Q3, which includes supplementary PMAs, PMAs, 510(k)s and HDEs. Of note in Q3 was Boston Scientific's Innova Vascular Self-Expanding Stent System, which gained a first PMA approval from FDA.

Not only did Minnesota's Medical Alley have the largest share of FDA approvals, we also posted the fastest approval times in several areas. Minnesota companies gained supplementary PMA approval 21 days faster than the national average for the top three sector categories - Cardiology, In Vitro Diagnostics (IVD) and Neurology - and 22 days faster across all categories.

In 510(k)s, Minnesota competed in two of the top three categories - Cardiology and Orthopedics - gaining clearance at least 27 days faster than the national averages of 133 and 120 days, respectively. Minnesota led in total approvals in Cardiology (38% of total) and Urology (67%).

Given the depth of regulatory expertise and demonstrable successes, Minnesota's Medical Alley should be the first place you look to bring medical technology to market.


View the full report

10.19.15_Quarterly FDA Approvals Report Q3 2015