FDA pegs Edwards Lifesciences Sapien delivery system recall as severest
(Reuters) – The U.S. health regulator on Thursday categorized the recall of Edwards Lifesciences Corp’s Sapien 3 Ultra delivery system…
Edwards Lifesciences, Medtronic heart valves win FDA approval for expanded use
(Reuters) – Heart valve systems from Edwards Lifesciences Corp and Medtronic Plc have been approved for use in a condition…
FDA ties three deaths to Edwards Lifesciences’ recalled heart devices
(Reuters) – The U.S. Food and Drug Administration said on Monday three deaths had been reported related to Edwards Lifesciences…