Cardiac Science Corporation, a group company of Opto Circuits (India) and a global leader in automated external defibrillators (AEDs), announced today that its Powerheart G5 AED with CRPD has received 510(k) market clearance from the U.S. FDA (Food and Drug Administration), allowing the company to begin selling the AED with CPRD along with its successful Powerheart G3 and G5 product line.
''This news is a testament to the commitment shown by our employees who have spent many years of developing, testing and refining the Powerheart G5 so that seasoned and first-time rescuers will have the most reliable, easy-to-use AED in the U.S. marketplace,'' said Vinod Ramnani, chairman and managing director, Opto Circuits (India). ''Our product portfolio is now the envy of the AED industry.''
The Powerheart family of AEDs is designed to enable rescuers to swiftly provide effective, life-saving therapy to aid a person who has suffered sudden cardiac arrest (SCA), a condition in which the heart suddenly stops beating due to ill regularities in its electrical system. The condition strikes as many as 360,000 Americans annually with the majority of cases being fatal, according to the American Heart Association.
Cardiac Science has been working to reduce SCA fatalities since it introduced the first fully automated external defibrillator.
The Powerheart G5 with CPRD will be available for purchase in the United States later this year.
Shares of the company gained Rs 1.5, or 7.61%, to trade at Rs 21.20. The total volume of shares traded was 698,220 at the BSE (10 a.m., Wednesday).