CardioDynamics International Corp. Receives FDA 510k Clearance for BioZ.com; The Next Generation Noninvasive Cardiac Output Monitor.SAN DIEGO--(BW HealthWire)--March 24, 1998--CardioDynamics International Corporation (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :CDIC CDIC Chronic Diseases In Canada (journal) CDIC Canadian Deposit Insurance Corporation CDIC Carbon Dioxide Information Center CDIC Center for Data Intensive Computing (BNL) ), a 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 manufacturer, 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. ) for the BioZ.com(TM), the company's next generation, noninvasive cardiac output monitor. The BioZ.com is the world's smallest, most cost-effective, full featured Thoracic thoracic /tho·rac·ic/ (thah-ras´ik) pectoral; pertaining to the thorax (chest). tho·rac·ic adj. Of, relating to, or situated in or near the thorax. Electrical Bioimpedance (TEB TEB Test & Evaluation Board TEB Third Eye Blind (band name) TEB Thread Environment Block TEB Turkiye Ekonomi Bankasi TEB Triethylborane TEB Technical Evaluation Board TEB Traffic Engineering Bureau (Pakistan) ) product. The BioZ.com features a transport battery, integrated blood pressure module, direct data interface with most hospital central monitoring systems, and ease of use. Commenting on the 510(k) marketing clearance for the BioZ.com, Richard E. Otto, chief executive officer of CardioDynamics, stated, "This clearance is yet another milestone in our quest to establish the BioZ family as a standard of care and further validates the company's position as a leader in the development and advancement of noninvasive monitoring systems. "The BioZ.com reflects the sophisticated demands of today's clinicians and has been engineered to meet the exacting clinical requirements of hospitals, as well as outpatient care clinics. The TEB-derived 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 provided by the BioZ.com can be incorporated into patient clinical records and healthcare information systems." The BioZ.com will join the company's current BioZ product line, the original BioZ and the Portable BioZ, as the noninvasive alternative to the costly, time consuming and potentially dangerous invasive Pulmonary Artery Catheterization Pulmonary Artery Catheterization Definition Pulmonary artery catheterization is a diagnostic procedure in which a small catheter is inserted through a neck, arm, chest, or thigh vein and maneuvered into the right side of the heart, in order to measure (PAC) procedure. The BioZ.com is the first product to fully utilize the company's proprietary Dynamic Impedance Signal Quantifier (logic) quantifier - An operator in predicate logic specifying for which values of a variable a formula is true. Universally quantified means "for all values" (written with an inverted A, LaTeX \forall) and existentially quantified means "there exists some value" (written with a (DISQ(TM)) technology, cleared by the FDA in September 1997. DISQ provides improved measurements of impedance waveforms and automatic electronic calibration, thereby increasing the repeatability and reliability of TEB measurements. Rhonda F. Pederson, President of CardioDynamics, stated, "Weighing less than 12 pounds and measuring only 14 x 12 x 7 inches, one quarter the size and weight of the original BioZ System, the BioZ.com broadens the company's market opportunities. "The BioZ.com will open the door to expedite sales to the European and Pacific Rim Pacific Rim, term used to describe the nations bordering the Pacific Ocean and the island countries situated in it. In the post–World War II era, the Pacific Rim has become an increasingly important and interconnected economic region. Communities, ambulance and additional emergency medical transportation services, managed care, outpatient clinics and physician offices. "With an estimated annual six million emergency room visits in the U.S. alone and an estimated $259 billion in annual U.S. healthcare U.S. Healthcare is a now-defunct healthcare company. The logo had an apple. The merger with Aetna In 1996, the company merged with Aetna, calling it Aetna U.S. Healthcare. The U.S. Healthcare apple logo was next to the Aetna name, and U.S. Healthcare under it. U.S. costs attributed to cardiovascular diseases, the BioZ.com has the potential to significantly reduce healthcare costs and dramatically impact the future of healthcare." CardioDynamics develops, manufactures, and markets noninvasive digital cardiac output monitoring devices, which provide continuous data on a wide range of hemodynamic parameters (measurements of the heart's ability to deliver oxygen-rich blood throughout the body). The company's primary products, the BioZ System, BioZ Portable, and BioZ.com, use TEB technology to obtain data which is typically available only through a time consuming, costly, potentially dangerous invasive PAC procedure. Since TEB monitoring is noninvasive, it eliminates patient risk and potentially decreases the length of hospital stay, thereby reducing patient cost. For additional information, please refer to the company's web site at http://www.cardiodynamics.com. Except for the historical and factual information contained herein, this press release contains forward-looking statements, the accuracy of which are necessarily subject to risks and 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 1997 Form 10-KSB. The company does not undertake to update the disclosures contained in this press release. CONTACT: CardioDynamics International Corp. Rhonda F. Pederson or Steve P. Loomis, 888/522-2342 rpederson@cardiodynamics.com sloomis@cardiodynamics.com |
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