Healthcare Industry News: cardiac monitor
News Release - April 26, 2006
Cardiac Science Receives FDA 510(k) Regulatory Clearance for New ElectrocardiographAtria 6100(TM) Combines Clinical Performance With Leading Edge Technology
BOTHELL, Wash., April 26 (HSMN NewsFeed) -- Cardiac Science Corporation (Nasdaq: CSCX ), a global leader in advanced cardiac monitoring and external 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 resting electrocardiograph, the Atria 6100. The new Atria 6100 electrocardiograph delivers the highest level of clinical performance while incorporating state-of-the-art technology to streamline clinical workflow, resulting in timely, high-quality, and accurate electrocardiogram (ECG) results critical for patient care. Cardiac Science expects to begin shipping the Atria 6100 to customers this quarter.
Cardiac Science provides a comprehensive line of electrocardiographs, which are devices that measure the electrical signals representing the rhythm of the heart at rest. The Atria 6100 represents the evolution of more than 35 years of expertise in electrocardiograph development and interpretive algorithm advancements, is designed for use in physician's offices and hospitals, and will be marketed under both the Burdick and Quinton brands. It offers all of the features of our traditional electrocardiographs with the additional benefit of advanced communications and storage features.
"Our engineering and marketing teams have developed a high performance, streamlined, feature-rich device that is extremely intuitive and easy to use, extending our already broad technology portfolio to the global primary and acute care markets," said Garry Norris, Cardiac Science vice president of marketing. "With the introduction of the new Atria 6100, we believe we have made another step towards our goal to become the worldwide provider of choice for cardiology-related products and services through leading technology and superior customer experience."
The new Atria 6100 is a state-of-the-art ECG device which includes options for both wired Ethernet applications and wireless 802.11 communications. The device features a new large color display for easy preview of electrocardiograph information, and storage for more than 150 patient records to improve clinical workflow in busy practices. Additionally, interpretive models include a pacemaker algorithm.
Like all Cardiac Science electrocardiographs, the Atria 6100 utilizes the proven University of Glasgow algorithm for interpretation, providing a silent second opinion. Unlike some competitive products, which limit algorithm criteria to age, the University of Glasgow algorithm, under continuous development since the 1970s, bases its analysis on five clinically significant criteria: gender, age, race, medication and classification. This is critical because ECG results for patients with different demographic profiles and medical conditions can vary greatly.
The Atria family of electrocardiographs, like many Burdick and Quinton brand electrocardiographs, can be integrated with Cardiac Science's ECG data management solutions, to take full advantage of sophisticated database and application technologies. In offices and clinics, we provide electronic storage and retrieval of patient ECG data that helps clinicians move away from time consuming and costly paper records. For hospitals, our Pyramis ECG data management system centralizes and organizes reports from multiple devices into single, readily accessible patient records. ECG results can be transmitted electronically from the exam room and imported by electronic medical records and cardiology management systems.
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. 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. Forward-looking statements in this press release include those that infer or imply that our latest electrocardiographs will be successful in the marketplace, resulting in increasing revenues and profits. These are forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. 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 10-k filed by Cardiac Science Corporation for the year ended December 31, 2005. Cardiac Science Corporation undertakes no duty or obligation to update the information provided herein.
Source: Cardiac Science
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