Jun 23, 2020

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.

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.

Arman Voskerchyan

Business Leader Therapeutic Care at Philips.

“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.”

FDA PMA information for the HeartStart FR3 and HeartStart FRx defibrillators can be found here and here, respectively. 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] Model 861388 and Model 861389

[2] Model 861304

About Royal Philips

Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people's health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2019 sales of EUR 19.5 billion and employs approximately 81,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.