Royal Philips (NYSE:PHG) said today the it won pre-market approval from the FDA for a pair of its automated external defibrillators, more than four years after the federal safety watchdog said it would require PMAs for AEDs that had already won 510(k) clearance.
The Dutch healthcare conglomerate said the FDA granted PMAs for its already-cleared HeartStart OnSite defibrillator and HeartStart Home defibrillators, including batteries, pad electrodes and other accessories. In January 2015, the FDA said it would require makers of automated external defibrillators to put their devices through the more rigorous PMA protocol. Today Philips said the HeartStart devices are the only AEDs available over the counter in the U.S.; HeartStart Home is the sole AED indicated for home use, the company said.
“We are committed to delivering high quality, innovative AEDs to provide personalized therapy to victims of sudden cardiac arrest,” therapeutic care business leader Arman Voskerchyan said in prepared remarks. “Pre-market approval for our HeartStart OnSite and HeartStart Home defibrillators, currently the only over-the-counter AEDs available in the U.S., reflects the robust work of our teams that delivered the strong and extensive technical, clinical and production data included in the PMA filing for these devices.”