FDA Grants Premarket Approval for Philips’ Automated External Defibrillators

The FDA has granted premarket approval to Philips’ HeartStart FR3 and HeartStart FRx automated external defibrillators (AEDs).

The FR3 device is a professional-grade product for first responders and medical staff that includes advanced features for treating cardiac arrest. The FRx is an emergency use AED that guides users with voice instructions.

Last year, the company received premarket approval for its HeartStart OnSite and HeartStart Home defibrillators, making them the only over-the-counter AEDs available in the U.S.