Healthcare Industry News: cardiac monitor
News Release - February 14, 2006
FDA Grants Cardiac Science 510(k) Clearance for New 'Crash Cart' DefibrillatorDefibrillator Will Be Sold Exclusively by GE Healthcare Worldwide
BOTHELL, Wash., Feb. 14 (HSMN NewsFeed) -- Cardiac Science Corporation (Nasdaq: CSCX ), a global leader in advanced cardiac monitoring and defibrillation products, announced today that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) regulatory clearance to market a new 'crash cart' defibrillator-monitor designed specifically for use by medical professionals to respond to cardiac emergencies in hospital settings. The new defibrillator will be sold exclusively by GE Healthcare (GE), a division of General Electric Company (NYSE: GE ) in accordance with previously concluded agreements.
Concurrent with this FDA clearance, GE has begun logistical preparations for the worldwide launch of the new defibrillator-monitor. The product will be sold to hospitals in the United States and Canada under the Cardiac Science Powerheart® brand, and to customers outside North America under the GE Responder® brand. GE will also continue distributing Cardiac Science's automated external defibrillators (AEDs) to hospitals worldwide, using the same branding approach as for the new defibrillator. Initial shipments of the new product are expected to take place during the second quarter of 2006.
"Working with GE, our engineering team has developed a streamlined, feature-rich device that is extremely intuitive and easy to use, extending our already broad technology portfolio to the traditional hospital defibrillator market. Our agreements with GE will enable effective access to the estimated $300 million in annual worldwide demand for hospital defibrillator-monitors," said John Hinson, Cardiac Science's Chief Executive Officer.
"We believe this attractive new product offers the right combination of features, weight, size and functionality required to compete in the worldwide hospital defibrillator market," said GE Healthcare's Vice President and General Manager, Diagnostic Cardiology, Matthias Weber, M.D. "GE's global presence in hospitals, physicians' offices and clinics, combined with world-class products from Cardiac Science, positions us to establish a leadership role in providing defibrillation technologies to healthcare providers."
About the new defibrillator-monitor
The new defibrillator-monitor is a lightweight, rugged and portable device with resuscitation and pacing therapies designed for use by professionals in medically-supervised environments to respond to cardiac emergencies. Similar to Cardiac Science's line of portable AEDs, the new device is extremely easy to use. Operators are guided by a combination of programmable text prompts, audible alarms and visible indicators.
The new defibrillator-monitor incorporates the company's patented STAR® biphasic escalating shock energy technology, which automatically adjusts the magnitude of the defibrillation shock based upon each patient's unique body type and also employs Cardiac Science's patented RHYTHMx® software, which provides heart rhythm analysis and shock advice to effectively address life- threatening arrhythmias.
About Cardiac Science Corporation
Cardiac Science Corporation develops, manufactures, and markets a family of advanced diagnostic and therapeutic cardiology devices and systems, including automated external defibrillators, electrocardiographs, stress test systems, Holter monitoring systems, hospital defibrillators, cardiac rehabilitation telemetry systems, patient monitor - defibrillators and cardiology data management systems. Cardiac Science Corporation also sells a variety of related products and consumables, and provides a comprehensive portfolio of training, maintenance and support services. The company is the successor to various entities that have owned and operated cardiology-related businesses, which sold products under the trusted brand names Burdick®, Powerheart®, and Quinton®. Cardiac Science Corporation is headquartered in Bothell, WA and also has operations in Lake Forest, California, Deerfield, Wisconsin, Shanghai, China, Copenhagen, Denmark and Manchester, United Kingdom.
Forward Looking Statements
This press release contains forward-looking statements, including, but not limited to, those relating to expectations regarding Cardiac Science Corporation's future revenue growth from sales of defibrillation products that involve a number of risks and uncertainties. These are forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "intend," anticipate," variations of such words, and similar expressions identify forward-looking statements, but their absence does not mean that the statement is not forward-looking. Actual results may vary significantly from the results expressed or implied in such statements. Factors that could cause or contribute to such varying results and other risks are more fully described in the registration statement on Form S-4/A that was filed by Cardiac Science Corporation under the name CSQ Holding Company on July 28, 2005, under the caption "Risk Factors," and in the Annual Reports of Quinton Cardiology Systems, Inc. and Cardiac Science, Inc. on Form 10-K for the year ended December 31, 2004, under the captions "Certain Factors that May Affect Future Results" and in other documents, we file with the Securities and Exchange Commission. Cardiac Science Corporation undertakes no duty or obligation to update the information provided herein.
Source: Cardiac Science
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.