FDA News Briefs for Tuesday, April 3, 2018April 3, 2018
These Food and Drug Administration (FDA) developments came in this week:
FDA Approves Supplemental PMA for Impella CP Heart Pump
Abiomed, Inc. has announced FDA approval for its Impella CP heart pump with SmartAssist, a “next-generation” model which incorporates a new opitical pressure sensor and changes to Abiomed Impella Controller. More Information.
FDA Advisory Committee Recommends Approval for Eversense CGM System
An FDA advisory panel has voted 8 to 0, that the Eversense long-term, implantable continuous glucose monitoring (CGM) system is safe and effective. The pending PMA for Eversense requests approval to market the device for measuring interstitial fluid glucose levels in adults with diabetes. More Information.