Royal Philips (NYSE:PHG) announced today that FDA has granted premarket approval for the company’s HeartStart FR3 and HeartStart FRx automated external defibrillators.
The HeartStart FR3 is a professional-grade AED. It includes advanced features for medical personnel and first-responders who need to treat a cardiac arrest.
The HeartStart FRx is a public-access AED. It features what Philips describes as intuitive, step-by-step voice instructions, including CPR guidance. The HeartStart FRx is intended for emergency use in workplaces, schools and other public spaces — as well as for medical professional use.
“We are pleased to receive premarket approval for our HeartStart FR3 and HeartStart FRx AEDs,” said Arman Voskerchyan, business leader of Therapeutic Care at Philips.
“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,” Voskerchyan said in a news release.
FDA last year approved Philips’ HeartStart OnSite and HeartStart Home defibrillators — the only over-the-counter AEDs available in the U.S. For the past five years, the agency has required AED makers to put their devices through the more rigorous PMA protocol.
