Philips Gets FDA Approval for Two New Defibrillators


Philips won FDA approval for its HeartStart FR3 and HeartStart FRx automated external defibrillators (AEDs). The HeartStart FR3 is an advanced device intended for use by medical professionals, including paramedics, and features such capabilities as “quick shock” to minimize hands-off time, and military-level ruggedness, ECG monitoring for non-cardiac arrest victims, and a battery that can deliver up to 300 shocks from a single charge.

The HeartStart FRx, on the other hand, is designed to be applied by bystanders to those nearby. It provides voice guidance, including on how to perform CPR properly, as well as a ticking metronome to help guide chest compressions. The device even has an infant/child mode, activated by inserting and turning an accompanying key, which changes the therapy settings and brings up the appropriate set of voice instructions. It’s as easy to operate as pushing the power button, placing the attached electrode pads where the image on the screen indicates, and then pushing the shock button when given the go-ahead by the device.

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

Product info pages: HeartStart FR3 and HeartStart FRx

Via: Philips

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