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Royal Philips NV

06/23/2020 | Press release | Distributed by Public on 06/23/2020 07:05

Philips receives FDA premarket approval for its HeartStart FR3 and HeartStart FRx automated external defibrillators

Amsterdam, the Netherlands and Cambridge, MA - Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced that the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) for the company's HeartStart FR3 [1] and HeartStart FRx [2] automated external defibrillators (AEDs), and their supporting accessories, including batteries and pads.

The HeartStart FR3 is a professional grade AED with advanced features to help medical personnel and first-responders treat cardiac arrest. The HeartStart FRx is a public-access AED that features intuitive, step-by-step voice instructions, including cardiopulmonary resuscitation (CPR) guidance, for emergency use in workplaces, schools and other public spaces, as well as for medical professional use.