Medtronic CEO weighs in on US vs EU regulation debate; defends handling of Infuse crisis
This article was originally published in Clinica
Executive Summary
Medtronic CEO Omar Ishrak believes the US FDA's approval process takes too long, and has suggested it should adopt a similar system to that used in Europe. In an interview published in the Financial Times, Mr Ishrak noted that in Europe, medical devices reach the market 18-24 months sooner than in the US, because the "response time is quicker, the clinical trial cycle is quicker, and maybe some of the barriers [to market entry] are less stringent".