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Cardiac Science gets US FDA 510(k) clearance to market Powerheart G-3 AED

IrvineTuesday, July 6, 2004, 08:00 Hrs  [IST]

Cardiac Science Inc announced that the US FDA has granted the company 510(k) clearance to market its new Powerheart G3-Automatic automated external defibrillator (AED), the first fully automatic AED in the Powerheart product line. This new generation AED has been designed specifically for public places, corporate settings and in-home use by consumers, according to a company release. A rescuer need only listen to the Powerheart's detailed voice instructions explaining how to attach the device to the heart attack victim to potentially save a life. There are no buttons to push or additional action required since the Powerheart analyzes the patient's condition to detect a life-threatening heart rhythm and, if appropriate, automatically delivers a potentially life-saving defibrillation shock(s) to restore the heart to a normal rhythm, company says in a release. Cardiac Science chairman and CEO Raymond W Cohen said, "Simplicity in design, robust Rescue-Ready self-testing technology, advanced detection algorithms in a package that promises maintenance-free operation combine to make the Powerheart G3-Automatic the easiest to use and safest AED on the market - bar none." The company announced in December that it had been granted a US patent that covers a publicly-available portable defibrillator capable of being used by a bystander to automatically deliver life-saving defibrillation shock(s) to a heart attack victim. AEDs are designed to quickly and easily provide a life-saving defibrillation shock to restore normal heart rhythm to a cardiac arrest victim. Cardiac Science develops, manufactures and markets the Powerheart brand, automated public access defibrillators (AEDs), and offers comprehensive AED/CPR training and AED programme management services that facilitate successful deployments.

 
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