Pre-Market Testing Guidance Pilot Program Released by FDA

Pre-Market Testing Guidance Pilot Program Released by FDA

The FDA is implementing a body of accredited testing facilities to streamline the medical device testing process internationally. The agency has released final guidelines for the program today (9/25) outlining the steps medical device companies must take in order to...
FDA Approves Edwards’ Sapien 3 for Cardiac Treatment

FDA Approves Edwards’ Sapien 3 for Cardiac Treatment

Edwards Lifesciences has developed the Sapien 3 transcatheter heart valve for cardiac treatment which was approved yesterday (9/8) by the U.S. Food and Drug Administration (FDA) for pediatric and adult patients. Transcatheter heart valves is an option for the new...