US FDA grants approval for Philips’ home defibrillatorsAugust 5, 2019
Royal Philips announced that the Center for Devices and Radiological Health (CDRH) of the US FDA has approved the company’s premarket approval (PMA) application for its HeartStart OnSite defibrillator and HeartStart Home defibrillator, and the relevant supporting accessories.
Philips’ HeartStart OnSite and HeartStart Home defibrillators are the only over-the-counter automated external defibrillators (AEDs) available to consumers in the US, while the HeartStart Home defibrillator is the only AED specifically indicated for home environment.
AEDs provide personalised therapy to victims of sudden cardiac arrest, the company said in a statement.
Royal Philips is a leading health technology company focused on prevention, to diagnosis, treatment and home care.