Medical Minute: FDA, European Union Medical Device Approvals | WABE 90.1 FM

Medical Minute: FDA, European Union Medical Device Approvals

Jul 21, 2016

On Thursday, WABE contributor Dr. Ford Vox and "Closer Look" host Jim Burress talked about how the European Union’s system for reviewing medical devices isn’t as rigorous as what the FDA here puts companies through. But a system Europeans might want to question nonetheless may benefit Americans who drink from the cup second.

For more information:

Hwang et al. Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study. BMJ. 2016 Jun 28;353:i3323. 

FDA. Unsafe and Ineffective Devices Approved in the EU that were Not Approved in the US. May 2012. 

FDA News Release. FDA approves first MRI-guided focused ultrasound device to treat essential tremor. July 11, 2016. 

Dr. Ford Vox is a medical journalist and commentator who has served as WABE 90.1’s medical analyst since 2015.