FDA grants Philips premarket approval for two HeartStart AEDs and accessories

Philips has announced it has received premarket approval for its HeartStart FR3 and HeartStart FRx automated external defibrillators, batteries, pads and other accessories from the FDA’s Centre for Devices and Radiological Health. The FR3 defibrillator is a professional grade AED with advanced features designed for medical personnel, and the FRx is an AED complete with step-by-step voice instructions and cardiopulmonary resuscitation guidance, designed specifically with the general public in mind to use during emergencies at work, in schools and other public, but is also for medical personnel to use.

Arman Voskerchyan, Business Leader Therapeutic Care at Philips, said: “We are pleased to receive premarket approval for our HeartStart FR3 and HeartStart FRx AEDs. 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.”