FDA staff doubt Cameron device better than rivals

The two takeaway’s I gleaned from this article on the Cameron ‘semi-implantable’ defibrillator that’s currently undergoing FDA approval for sale in the US are;

U.S. medical device reviewers said the first defibrillator designed to be implanted directly under the skin may cause more infections, and work less quickly, than similar devices implanted in the heart, raising doubts that Cameron Health Inc’s novel product would attract patients.

[...]

But the device reviewers said they would not approve it until the company resolved issues with a battery that depletes earlier than it should.

There’s already been numerous reported issues with external devices in the US where the batteries were either depleted prematurely, or where people / businesses had bought defibs and have not paid enough attention to the battery levels until it was too late, therefore leaving insufficient charge.

I certainly suggest to anyone who will listen that they need to subscribe to the FDA’s recall alerts, particularly when it comes to defibrillators and other medical devices.

(Via Chicago Tribune.)

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