ADAC Receives FDA 510k Clearance to Market MCD/ACTM.MILPITAS, Calif.--(BW HealthWire)--Oct. 27, 1997--ADAC Laboratories (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 :ADAC) announced today 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 Molecular Coincidence Detection with Attenuation Correction (MCD/ACTM) in the United States. MCD/AC is an enhancement to ADAC's MCD system that corrects for image distortions created by non-uniform attenuation of soft tissue in the human body. MCD technology allows ADAC's nuclear medicine imaging nuclear medicine imaging, n the diagnostic imaging field that evaluates organ function by injecting isotopes into a structure and documenting the amount of radiation emanating from the tissues. systems to perform both Single Photon Emission Computed Tomography single photon emission computed tomography n. Abbr. SPECT Tomographic imaging of local metabolic and physiological functions in tissues. ("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 previously available only on expensive dedicated Positron Emission Tomography positron emission tomography: see PET scan. positron emission tomography (PET) Imaging technique used in diagnosis and biomedical research. ("PET") imaging systems. R. Andrew Eckert, Chief Executive Officer of ADAC Laboratories, stated, "Receiving FDA 510(k) clearance for MCD/AC is a major milestone. It clears the way to begin receiving orders, manufacturing, and delivering this new technology to our customers. MCD/AC has the potential to enable more widespread use of MCD imaging, which we believe will provide significant clinical value and economic benefits in the era of managed care. ADAC clearly is setting the standard in the rapidly developing coincidence imaging marketplace." ADAC Laboratories is the world market share leader in nuclear medicine and a supplier of radiation therapy planning systems and radiology, laboratory, and cardiology information systems in North America. In 1996, ADAC became the first healthcare manufacturer to receive a 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 . ADAC is headquartered in Milpitas, CA, with its Healthcare Information Systems division in Houston, TX. This press release contains forward-looking statements. Factors that could cause actual results to differ materially from those contained in such forward-looking statements include those factors set forth under "Business Considerations" in the Company's most recent Form 10-Q. All forward-looking statements are based on information available to the Company on the date hereof, and the Company assumes no obligation to update such statements. CONTACT: ADAC Laboratories, Milpitas Heidi Magner, 408/321-9100 |
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