The HeartStart FR3 is a professional-grade AED with advanced features, while HeartStart FRx is a public-access AED that offers step-by-step voice instructions
Both devices have been marketed to date under FDA premarket notifications (510(k)).(Credit: Koninklijke Philips N.V.)
Royal Philips has secured premarket approval (PMA) from the Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA) for its HeartStart FR3 and HeartStart FRx automated external defibrillators.
The PMA approval is also applicable for their supporting accessories, including batteries and pads.
Philips has added advanced features to the HeartStart FR3 defibrillator to better support medical personnel and first-responders for the treatment of cardiac arrest.
The HeartStart FRx is a public-access AED that offers step-by-step voice instructions, including cardiopulmonary resuscitation (CPR) guidance, for emergency use in workplaces, schools, and other public spaces. It can also be used for medical professional use.
According to the company, both devices have been marketed to date under FDA premarket notifications (510(k)), but are now approved under PMA.
Philips already provides PMA-approved HeartStart OnSite and HeartStart Home defibrillators
Last year, Philips secured PMA approval for its HeartStart OnSite and HeartStart Home defibrillators, which are claimed to be only over-the-counter AEDs available to consumers in the US.
Philips therapeutic care business leader Arman Voskerchyan said: “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.”
In May, Philips secured 510(k) clearance from the FDA for its next-generation wearable biosensor to better manage confirmed and suspected Covid-19 patients in the hospital.