FDA Holds Up Edwards-DexCom Continuous Glucose Monitor For Hospital Use
This article was originally published in The Gray Sheet
Edwards Lifesciences' and DexComs’ first-of-its-kind continuous glucose monitor for hospital use is running into delays at FDA.
You may also be interested in...
Product approvals and launches from Cardiva, Medtronic and more.
FDA is encouraging industry to submit study designs for newer, more accurate continuous glucose monitors for hospital use. It gathered experts at a June 25 public meeting to discuss questions around indications for use and trial designs.
Edwards Lifesciences expects FDA approval of its Sapien transcatheter aortic heart valve replacement “any day,” CEO Michael Mussallem said Oct. 19.