Not all AEDs are created equal.
When it comes to life-saving equipment, one detail matters more than most people realise:
Is the device FDA Premarket Approved?
The U.S. Food and Drug Administration (FDA) is one of the most rigorous regulatory bodies in the world.
Premarket Approval (PMA) is not a simple registration — it requires clinical evidence, safety validation, and proven performance.
Why this matters:
• Proven to deliver therapy safely and effectively
• Tested against real-world cardiac arrest scenarios
• Built to perform under pressure — when seconds count
• Backed by long-term data, not assumptions
In an emergency, there is no room for uncertainty.
No time to question the device.
No margin for error.
Choose technology that’s been proven — not just approved on paper.
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 and HeartStart 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
