FDA staff doubt Cameron device better than rivals
WASHINGTON, April 23 |
WASHINGTON, April 23 (Reuters) - U.S. medical device reviewers said Cameron Health Inc's defibrillator implanted under the skin may have more infection issues, and work less quickly, than similar devices implanted in the heart.
The reviewers from the U.S. Food and Drug Administration also said they would not approve Cameron Health's defibrillator, which treats a dangerously irregular heartbeat, until the company resolved issues with a battery that depletes earlier than it should.
The FDA staff review, posted online on Monday, comes ahead of an advisory panel of outside experts, which will vote on the device on Thursday.
Boston Scientific Corp agreed to buy Cameron Health Inc in March.
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