US FDA OKs over-the-counter defibrillator sales

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The U.S. Food and Drug Administration on Thursday approved a medical device maker’s request to sell at-home heart defibrillators without a prescription.

Philips Medical Systems, a unit of Dutch group Philips Electronics NV, had asked regulators to allow over-the-counter sales of its automated external defibrillator to treat patients in cardiac arrest.

The device, which costs about $2,000, had been available with a prescription, but Philips said many physicians were unwilling to prescribe it. 

Cardiac arrest accounts for more than 340,000 U.S. deaths each year, according to American Heart Association estimates. Eighty percent of cases occur in homes. 

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