FDA grants premarket approval for Philips’ home defibs

The FDA’s Centre for Devices and Radiological Health (CDRH) has granted premarket approval for Philips’ HeartStart OnSite defibrillator and HeartStart Home defibrillator, together with the respective accessories. The HeartStart OnSite and HeartStart Home defibrillators already have FDA 510(k) clearance, and are the only over-the-counter automated external defibrillators available to consumers in the US. The HeartStart Home defibrillator is the only automated external defibrillator specifically indicated for use in the home.
Arman Voskerchyan, Philips’ Business Leader Therapeutic Care, said: “We are committed to delivering high quality, innovative AEDs to provide personalized therapy to victims of sudden cardiac arrest. Premarket approval for our HeartStart OnSite and HeartStart Home defibrillators, currently the only over-the-counter AEDs available in the US, reflects the robust work of our teams that delivered the strong and extensive technical, clinical and production data included in the PMA filing for these devices.”