CardioDynamics Announces FDA 510`k' Approval for BioZtect Sensors.Business Editors, Health/Medical Writers SAN DIEGO--(BW HealthWire)--May 11, 2000 New Proprietary Sensors Utilize Patented Technology and Operate Exclusively with Company's BioZ.com(R) Systems 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 output cardiac output n. Abbr. CO The volume of blood pumped from the right or left ventricle in one minute. It is equal to the stroke volume multiplied by the heart rate. monitoring systems, today announced that it has received 510(k) approval 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. ) for its new proprietary BioZtect sensors. The Company is licensing incorporated patented features for the BioZtect sensors and also intends to file patents covering additional unique features of the new design. The new proprietary BioZtect sensors offer notable improvements in performance and safety. Since signal transmission and detection are critical for device performance, the BioZtect was designed to ensure that users exclusively utilize the sensors with the Company's BioZ.com software and hardware. The new design, coupled with software enhancements to the BioZ.com product, will alert the user of faulty patient contact or a malfunction in the sensors or cable. Customers will also benefit from the new sensors' unique shape and electrode chemistry, which optimize electrical signal transmission and maximize skin adhesion. "As the innovator in the noninvasive cardiac monitoring industry, it is our responsibility to provide our customers with the latest in technological advancements. Our new BioZtect sensors are designed to improve system performance and safety," stated Michael K. Perry, CardioDynamics' Chief Executive Officer. "BioZtect will enable us to strengthen customer loyalty and, at the same time, increase our Company's revenue stream from disposable sensors. We anticipate that over time the revenue from our disposable sensors will grow to a sizable level, potentially 40% of total revenue." 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 Impedance Cardiography (ICG ICG indocyanine green. ), DISQ(TM) technology, and the Z MARC(TM) algorithm 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 previously not 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. ) noninvasively 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 Harvard Brigham & Women's (Boston), Mayo Clinic (Rochester), UCSF UCSF University of California at San Francisco Stanford Health Care (Palo Alto), 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). 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-Ganzb 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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