Cardiac Science Receives FDA Clearance to Market Holter ECG Recorder.IRVINE, Calif.--(BW HealthWire)--Sept. 10, 1997--Cardiac Science Inc. (OTC/BB:DFIBD) announced it has received clearance from the U.S. Food and Drug Administration to market its new Holter ECG ECG electrocardiogram. ECG abbr. 1. electrocardiogram 2. electrocardiograph ECG Also called an electrocardiogram, it records the electrical activity of the heart. cassette recorder, DM-400. "Receiving FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. clearance demonstrates our ability to design and manufacture medical products in accordance with U.S. regulatory standards and procedures. It also demonstrates our ability to navigate the regulatory system," said Raymond W. Cohen cohen or kohen (Hebrew: “priest”) Jewish priest descended from Zadok (a descendant of Aaron), priest at the First Temple of Jerusalem. The biblical priesthood was hereditary and male. , president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . The DM-400 510(k) application is one of two FDA 510(k) applications Cardiac Science submitted last spring. The company is awaiting FDA clearance for the Powerheart AECD AECD Automatic external cardioverter-defibrillator A device that monitors cardiac rhythm and automatically defibrillates (Automatic External Cardioverter Defibrillator defibrillator, device that delivers an electrical shock to the heart in order to stop certain forms of rapid heart rhythm disturbances (arrhythmias). The shock changes a fibrillation to an organized rhythm or changes a very rapid and ineffective cardiac rhythm to a ). Cardiac Science developed the Powerheart Automatic External Cardioverter Defibrillator (AECD), a non-invasive, hospital bedside device that monitors and detects life-threatening heart rhythms and automatically administers a defibrillation Defibrillation Definition Defibrillation is a process in which an electronic device sends an electric shock to the heart to stop an extremely rapid, irregular heartbeat, and restore the normal heart rhythm. shock without human intervention should a patient suffer cardiac arrest. Cardiac Science also manufactures PC-based Holter ECG systems and Holter recorders and distributes these products in the United States in more than 40 countries through its subsidiary, Diagnostic Monitoring. For more information, visit the Cardiac Science Web site at www.cardiacscience.com . -0- This news release contains forward-looking statements within the meaning of the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended, which involve risks and uncertainties, including, but not limited to, economic, competitive, governmental and technological factors affecting the company's operations, markets, products, services and prices, and other factors. The company's actual results could differ materially from those projected in the forward-looking statements as a result of the factors described herein. CONTACT: Cardiac Science Inc., Irvine Raymond W. Cohen, 714/587-0357 or Financial Sciences of America Fran Daniels, 310/278-4413 |
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