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.

Annual Report: Approvals 2015

Key Findings

  • US 510(k) clearances decline 26% in 2015, the lowest in 5 years, while OUS clearances surge 51%
  • China continues trend of steady growth in 510(k) clearances while European and Asian countries see dramatic 2015 spike
  • Cardiology top sector for original PMAs while orthopedics dominant sector for 510(k) clearances
  • Minnesota remains fastest medical technology hub for 510(k) clearances across all experience levels
  • Minnesota companies secured 11 original PMAs, 8 in cardiology, which is 4-times more than second place California
  • Globally, Minnesota companies top the list of recipients of approvals and clearances in 2015

View the Report

2015 Annual Approval Report _Page _01

2015 Annual Approval Report _Page _03