Philips Earns Premarket Approval for Defibrillators
Philips received premarket approval from the FDA for two over-the-counter defibrillator devices, the HeartStart OnSite and HeartStart Home.
The two products are the only OTC automated external defibrillators (AEDs) approved by the agency, the company said, noting that the products previously received 510(k) clearance.
The HeartStart Home defibrillator is the only AED specifically indicated for use at home. The device provides step-by-step voice commands and guidance on cardiopulmonary resuscitation.