FDA Spotlights 'Prominent Risks' Of Cameron Defibrillator

Law360, New York (April 23, 2012, 3:34 PM EDT) -- Boston Scientific Corp., which is betting up to $1.3 billion on a Cameron Health Inc. defibrillator implant, received mixed feedback Monday on the device’s safety and effectiveness from the U.S. Food and Drug Administration in advance of a crucial advisory panel vote.

The prime selling point of the subcutaneous defibrillator is that it’s relatively noninvasive, resting beneath the skin and not requiring wires to be woven into the heart and blood vessels.

In a report for the panel's meeting Thursday, FDA staffers praised that as the...
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