ADAC Receives FDA Approval for Molecular Coincidence Detection.MILPITAS, Calif.--(BUSINESS WIRE)--Nov. 27, 1995--ADAC Laboratories (ADAC/NASDAQ) announced today that it has just received formal clearance from the 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 Molecular Coincidence Detection (MCD) product for use in ADAC's nuclear medicine camera systems. The Company made the announcement at the Radiological Society of North America The Radiological Society of North America (RSNA), founded in 1915, has the purpose to "promote and develop the highest standards of radiology and related sciences through education and research". annual meeting in Chicago, Illinois. ADAC ADAC Allgemeiner Deutscher Automobil Club (German automobile club) ADAC Aboriginal Drug and Alcohol Council ADAC Art Directors and Artists Club (Sacramento, California) ADAC Alcohol and Drug Abuse Council believes that MCD is a breakthrough technology which is designed to enable ADAC's VERTEX EPIC(TM) and SOLUS Solus® Cardiology An ASIR, single-chamber, rate-modulated pulse generator. See Pacemaker. EPIC(TM) gamma cameras to perform both single photon emission computerized tomography (SPECT SPECT single-photon emission computed tomography. SPECT abbr. single photon emission computed tomography SPECT, n See single photon emission computer tomography. ) and coincidence imaging procedures. Coincidence imaging, previously only available on very costly dedicated positron emission tomography positron emission tomography: see PET scan. positron emission tomography (PET) Imaging technique used in diagnosis and biomedical research. (PET) systems, offers valuable diagnostic information for a number of oncologic, cardiac and neurological conditions. David L. Lowe, Chief Executive Officer, stated, "We believe that FDA notification on MCD is a major milestone for both our Company and our industry. This breakthrough technology is expected to significantly improve patient management while lowering the cost of care. MCD has the potential to expand the market for nuclear medicine instrumentation by bringing the benefits of PET technology, previously available only in a limited number of institutions, to all nuclear medicine departments." ADAC will start multi-center trials with MCD in early 1996. These trials are expected to document the clinical efficacy of MCD while verifying the significant reduction in the costs of managing cancer patients relative to conventional diagnostic techniques. ADAC Laboratories is the world market share leader in nuclear medicine and a leading supplier of radiology and laboratory information systems in North America. For the second consecutive year, ADAC has received a site visit for the prestigious Malcolm Baldrige National Quality Award The Malcolm Baldrige National Quality Award is given by the United States National Institute of Standards and Technology. Through the actions of the National Productivity Advisory Committee chaired by Jack Grayson, it was established by the Malcolm Baldrige National Quality . The Company headquarters is in Milpitas, California. CONTACT: ADAC Laboratories, Milpitas Kathleen Call, 408/321-9100 |
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