FDA Advisers Back Cameron Health Heart Device
Anna Yukhananov, The Chicago Tribune
WASHINGTON (Reuters) - U.S. drug advisers gave the nod to the first defibrillator designed to be implanted directly under the skin, raising hopes Cameron Health Inc's novel product would be approved.
Outside advisers to the U.S. Food and Drug Administration voted 7-1 to recommend approval of Cameron's device, which delivers electrical shocks to a dangerously irregular heartbeat to return it to a normal rhythm. They also voted 7-1 that the device worked and unanimously said it was safe, according to the company and the FDA.