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FORT LAUDERDALE, Fla., Jan. 14 /PRNewswire/ -- Imaging Diagnostic Systems, Inc. (OTC Bulletin Board: IMDS - news) announced today that the FDA has granted approval (letter dated Dec. 17, 1997) to include specific studies on augmented breasts as part of an extensive in-house study of the CT Laser Mammography (CTLM(R)) device for breast imaging. This testing is designed to develop diagnostic criteria for CTLM images.
A prominent university medical center has agreed to participate with Imaging Diagnostic Systems, Inc. to expand the first-phase clinical study to prepare for acquiring data that will be part of the final pre-market application (PMA).
Immediately thereafter, expanded clinical trials will commence in hospitals in Miami, Chicago, Los Angeles, Boston, and New York. At the conclusion of these studies the PMA data will be submitted to the FDA.
Imaging Diagnostic Systems, Inc., is developing the first patented laser- based system for detecting breast abnormalities which requires no breast compression or use of radiation. The CTLM produces three-dimensional cross- sectional images of the breast in a non-invasive procedure known as Computed Tomography Laser Mammography.
SOURCE: Imaging Diagnostic Systems, Inc.
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