CardioDynamics International --CDIC-- Receives FDA 510k Clearance for BioZ.pc--TM--.Business Editors and Health/Medical Writers SAN DIEGO--(BW HealthWire)--July 7, 2000 Company Launching Proprietary Technology with Internet-Based Information Management Capabilities CardioDynamics International Corporation (Nasdaq: CDIC CDIC Chronic Diseases In Canada (journal) CDIC Canadian Deposit Insurance Corporation CDIC Carbon Dioxide Information Center CDIC Center for Data Intensive Computing (BNL) ), manufacturer of BioZ(R) noninvasive digital cardiac function monitoring systems, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (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. ) to market its new BioZ.pc(TM) System. The Internet-ready BioZ.pc combines the Company's proprietary noninvasive Impedance Cardiography (ICG ICG indocyanine green. ) technology with the wide-spread capabilities of the Internet. Michael K. Perry, CardioDynamics Chief Executive Officer, stated, "The BioZ.pc is the first product from our platform development program that is being leveraged into future ICG systems, modules, and additional medical company products. The BioZ.pc combines our proprietary measurement capabilities with a laptop computer, which then transmits the results to a central file server. The physician can review the transmitted patient data via the Internet or electronic fax. We are pleased to continue our record of fast-track product development and rapid FDA clearances, which are important in capitalizing on healthcare market needs." The BioZ.pc will assist in expanding CardioDynamics' market reach by providing noninvasive cardiac function data to physicians who would not otherwise purchase a stand alone BioZ device. The BioZ.pc is expected to be launched during the Company's fiscal third quarter and will be marketed by Profiles in Health as a component to their Proveillance(TM) System. CardioDynamics, with headquarters in San Diego, is a medical technology and information solutions company committed to fundamentally changing the way hemodynamic monitoring hemodynamic monitoring Clinical medicine A general term for the ongoing evaluation of hemodynamics is performed in healthcare. The Company's primary products, the BioZ(R) System and BioZ.com(R), utilize proprietary BioZ Impedance Cardiography (ICG) technology to noninvasively provide medical professionals with hemodynamic he·mo·dy·nam·ics n. (used with a sing. verb) The study of the forces involved in the circulation of blood. he data not previously available in the physician's office and many hospital settings. Just as Electrocardiography electrocardiography (ĭlĕk'trōkärdēŏg`rəfē), science of recording and interpreting the electrical activity that precedes and is a measure of the action of heart muscles. (ECG ECG electrocardiogram. ECG abbr. 1. electrocardiogram 2. electrocardiograph ECG Also called an electrocardiogram, it records the electrical activity of the heart. ) measures the heart's electrical characteristics, ICG makes it possible to noninvasively measure the heart's mechanical (blood flow) characteristics. Physicians around the world are currently using the BioZ products, including major medical centers such as the Mayo Clinic (Rochester), Stanford University School of Medicine Stanford University School of Medicine is affiliated with Stanford University and is located at Stanford University Medical Center in Stanford, California, adjacent to Palo Alto and Menlo Park. , (Palo Alto), University of California The University of California has a combined student body of more than 191,000 students, over 1,340,000 living alumni, and a combined systemwide and campus endowment of just over $7.3 billion (8th largest in the United States). San Francisco (San Francisco), Yale New Haven Hospital (New Haven), and Baylor College of Medicine Baylor College of Medicine is a private medical school located in Houston, Texas, USA on the grounds of the Texas Medical Center. It has been consistently rated the top medical school in Texas and among the best in the United States. (Houston). The worldwide market potential for BioZ products is estimated to be $5 billion, together with an additional $800 million in recurring annual revenue for disposables. For additional information, please refer to the company's Web site at www.cdic.com. Forward-Looking (Safe Harbor) Statement: Note: Except for the historical and factual information contained herein, this press release contains forward-looking statements, the accuracy of which are necessarily subject to uncertainties and risks, which include sole dependence on the BioZ product line, competition from Baxter Healthcare Corp. (manufacturer of the Swan-Ganz(R) device), further capital requirements, and various uncertainties characteristic of companies just emerging from the development stage; as well as other risks detailed in the company's filings with the SEC, including its 1999 Form 10-KSB. The company does not undertake to update the disclosures contained in this press release. |
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