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Myocardial Infarction

FDA clearance granted to market defibrillator

Published in Cardiovascular Week, September 1st, 2003

Cardiac Science, Inc., (DFIB) announced that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance to market its new Powerheart AED G3 (automated external defibrillator), designed 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% less to produce than Cardiac Science's current model and the company expects the higher gross margins to translate directly into operating profits.

Cardiac Science president and CEO Raymond W. Cohen said, "We will begin immediate shipments to end users, distributors and OEM...

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