Daxor Announces FDA Clearance of the Blood Volume Analyzer -- BVA-100.NEW YORK--(BUSINESS WIRE)--Sept. 30, 1997--The Daxor Corporation has received 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. clearance to market its Blood Volume Analyzer, the BVA-100. The instrument is designed to measure the total amount of blood in the human body. Daxor has obtained patents in the United States, Europe and Japan for the BVA-100. Development of the BVA-100 began in 1985. The application for the FDA clearance was submitted on November 4, 1996. The BVA-100 is the only instrument designed to measure human blood volume that has been awarded a US patent. The accurate measurement of blood volume is important in situations such as surgery and other conditions where a blood transfusion blood transfusion, transfer of blood from one person to another, or from one animal to another of the same species. Transfusions are performed to replace a substantial loss of blood and as supportive treatment in certain diseases and blood disorders. may be needed. Standard tests such as the commonly used hemoglobin or hematocrit Hematocrit Definition The hematocrit measures how much space in the blood is occupied by red blood cells. It is useful when evaluating a person for anemia. Purpose Blood is made up of red and white blood cells, and plasma. tests to determine blood loss measure the thickness of blood, but not the actual volume. The hematocrit test may be particularly inaccurate in a situation of sudden blood loss, as for example, in surgery. The BVA BVA British Veterinary Association (London, UK) BVA Blinded Veterans Association BVA Board of Veterans' Appeals BVA Bond Van Adverteerders (Dutch Association of Advertisers) BVA British Video Association will provide a measurement of blood volume within 25 to 35 minutes, accurate to plus or minus 2%. Fear of contaminated transfusions has caused physicians to withhold transfusions until significant blood loss has occurred. This change in transfusion guidelines transfusion guidelines Transfusion medicine Guidlelines for use of blood components, which are usually written in a hospital's policy manual. See Transfusion criteria, Transfusion medicine. has made it particularly important that an accurate measure of the total amount of blood within a patient be obtainable. Between three and four million Americans receive blood transfusions each year. The instrument is designed for use in both hospitals and outpatient facilities. The BVA-100 is manufactured for Daxor by Oxford Instruments in Oak Ridge, Tennessee Oak Ridge is an incorporated city in Anderson and Roane Counties in East Tennessee, about 25 miles northwest of Knoxville. Oak Ridge's population was 27,387 people at the 2000 census. . The BVA may be used independently, but is designed to be used in conjunction with a disposable radio isotope kit containing Albumin-131. The kit is protected by a US patent, with patent protection pending in both Europe and Japan. The kit is currently under a separate FDA review. Application for the release to market was submitted to the FDA on February 4, 1997 and is currently pending. For further information please contact Dr. Joseph Feldschuh, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. or Andrea Webber. CONTACT: Daxor Corporation Joseph Feldschuh or Andrea Webber, 212/244-0555 |
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