Cardiac Science Receives FDA 510(k) Clearance to Market Its New Powerheart(R) G3 Automated Public Access Defibrillator
Monday August 4, 1:30 am ET
Clears Path for Shipments Into U.S. Market
IRVINE, Calif., Aug. 4 /PRNewswire-FirstCall/ -- Cardiac Science, Inc. (Nasdaq: DFIB - News) today announced that the U.S. Food and Drug Administration has granted the Company 510(k) clearance to market its new Powerheart® AED G3 (automated external defibrillator), designed to be the easiest-to-use and most technologically advanced automated defibrillator for use by lay persons and trained professionals in the corporate, public access, municipal, home and medical markets. The new G3 AED product line costs approximately 30 percent less to produce than Cardiac Science's current model and the Company expects the higher gross margins to translate directly into operating profits.
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Cardiac Science President and CEO Raymond W. Cohen said, "We will begin immediate shipments to end users, distributors and OEM partners in the United States and around the world including our newest partner, GE Medical Systems. Designing a superior AED at a significantly lower production cost and getting it from conception to market in under twelve months is a result of the progressive culture at Cardiac Science and represents a significant dividend on our R&D investment."
The Powerheart AED G3 is fully automated and offers user-friendly features such as one-button operation and intuitive voice commands that guide users through the rescue process. Patented RescueReady® technology ensures that the AED will always be functional and ready when needed to rescue a heart attack victim. Daily self-testing for the presence and functionality of the device's pre-connected defibrillation electrodes, self-contained battery system and hardware components ensures reliability and offers distinct advantages as compared to competitive devices. The G3 also incorporates the Company's patented RHYTHMx® analysis software which boasts 100 percent sensitivity in detecting life-threatening heart rhythms and its STAR® biphasic shocking engine which, based on each patient's unique physiology, determines the amount of energy needed to successful jump-start the victim's heart. |
