RELA, Colorado MEDtech Subsidiary Contracted to manuf. Heart Defribrillator
Cardiac Science Contracts With RELA Inc. to Manufacture Its Automatic External Cardioverter Defibrillator
IRVINE, Calif.--(BW HealthWire)--Oct. 7, 1997--Cardiac Science Inc. (OTC/BB:DFIBD) announced that it has entered into an agreement with RELA Inc., a medical device manufacturer, to complete the development and begin production of the commercial model of Cardiac Science's automatic external cardioverter defibrillator called the Powerheart.
''RELA is an established and well-respected medical device developer and manufacturer. They have a reputation for fulfilling exact product requirements and for meeting schedules in a timely manner,'' said Raymond W. Cohen, president and CEO. ''We anticipate out-sourcing to RELA will enable us to enter the market sooner and will reduce production expenditures.''
RELA's manufacturing facility complies with ISO 90001, EN 46001 and the FDA's quality system standards. RELA, located in Boulder, Colo., has operated since 1977, and is a wholly owned subsidiary of Colorado MEDtech Inc., a publicly held company (NASDAQ:CMED).
Cardiac Science is committed to developing proprietary devices that increase the survival rates of cardiac arrest victims. In February 1997, the company filed a 510(k) with the U.S. Food and Drug Administration for 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 shock without human intervention should a patient suffer cardiac arrest.
Sale of the Powerheart in the United States is subject to clearance from the FDA. Cardiac Science also manufactures PC-based Holter ECG systems and Holter recorders and distributes these products in the United States and in more than 40 international countries through its subsidiary, Diagnostic Monitoring.
For more information, visit the Cardiac Science Web site at cardiacscience.com
NOTE: 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. |