FDA panel rejects CardioMEMS' heart failure monitor
8 against approval of CardioMEMS' implantable pressure measurement system in heart failure patients. The FDA had asked the panel to review clinical trial results to determine if the Champion heart failure monitoring system was safe and effective. ...
Heart Failure Device Rejected By FDA Committee
FDA Advisory Panel Recommends Against Approval of Champion® Heart Failure ...
FDA panel votes against approving wireless heart monitor