FDA Advisory Panel Backs Cameron's New Defibrillators

Law360, New York (April 26, 2012, 10:09 PM EDT) -- Cameron Health Inc. announced Thursday that a U.S. Food and Drug Administration advisory panel had voted overwhelmingly to recommend that the FDA approve its new implantable defibrillators, despite mixed feedback in an agency report released earlier this week.

The Circulatory System Devices Panel of the FDA's Medical Devices Advisory Committee voted 7-1 that there's sufficient data about the efficacy and safety of Cameron's S-ICD System, a subcutaneous, implantable cardio-defibrillator for treating sudden cardiac arrest. The prime selling point of the subcutaneous defibrillator is that it’s relatively noninvasive,...
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