Philips receives FDA approval for automated external defibrillators

Public-access AEDs to treat cardiac arrest

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The HeartStart FR3

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.

Bystanders use AEDs

“We are pleased to receive premarket approval for our HeartStart FR3 and HeartStart FRx AEDs,” said Arman Voskerchyan, business leader Therapeutic Care at Philips. “This complements the premarket approval that we received last year for our HeartStart OnSite and HeartStart Home AEDs. Our industry leading portfolio of AEDs is instrumental in helping save the lives of numerous sudden cardiac arrest victims in the U.S. and worldwide. We look forward to continuing to meet our commitment to our medical professional and public-access customers, and especially to the victims of sudden cardiac arrest who rely on our AEDs.”

These devices have been marketed to date under FDA premarket notifications (510(k)), but are now approved under PMA. In 2019, Philips received PMA approval for its HeartStart OnSite and HeartStart Home defibrillators, which are the only over-the-counter AEDs available to consumers in the U.S.

1 COMMENT

  1. Interesting technology, ever smaller, battery-operated I suppose and less expensive and available for use where it is needed. I wonder when this will come to India and what will be steps for its approved use here. Equally of interest is whether these devices can be checked for calibration using a cloud-based technology or will they have to be taken into a Philips service center for that?

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