Imaging Diagnostic to install advanced CT Laser Mammography system in Harrington Cancer Center

Fort Lauderdale 11 June 2002Imaging Diagnostic Systems Inc. has installed its Computed Tomography Laser Mammography (CTLM) system at the Don and Sybil Harrington Cancer Center, a Comprehensive Breast Center located in Amarillo, Texas, under the FDA-approved IDE programme. This programme permits the company to place ten systems in key geographic locations, recoup equipment and installation costs, collect clinical data, and construct the clinical atlas.

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Dr. John "Chip" Coscia is Director of Clinical Breast Radiology at the Comprehensive Breast Center and the area's first clinical breast radiologist. Dr. Coscia will be overseeing the CTLM project at the Harrington Cancer Center.

The Comprehensive Breast Center offers screening and diagnostic mammography, breast ultrasound, cyst aspiration, non-surgical ultrasound and stereotactic guided breast biopsy, needle-wire localisation, pneumocystography, ductography, patient education and second opinion consultation. The mobile mammography outreach programme works in co-operation with area physicians and health agencies to provide breast cancer screenings to communities throughout the Texas Panhandle and portions of the surrounding states.

The Don and Sybil Harrington Cancer Center is a non-profit, free-standing, outpatient cancer centre, serving patients in the entire Texas Panhandle, eastern New Mexico, sections of Oklahoma, southeast Colorado, and southwest Kansas. The mission of the Harrington Cancer Center is to reduce the burden of cancer and blood diseases through patient care, education, and research.

Imaging Diagnostic Systems has received CE Marking, UL listing, ISO 9002 certification and FDA export certification permitting the company to market its product internationally. The company is seeking PreMarket Approval (PMA) from the Food and Drug Administration (FDA) for its CTLM system to be used as an adjunct to mammography to aid in the detection of breast abnormalities.

Under the new modular submission approach, the company's PMA application has been divided into different modules, each of which will contain documentation required for the FDA review. The FDA has accepted all four modules and the company is currently completing the PMA application as the final submission of the FDA approval process.

Imaging Diagnostic Systems Inc. has developed the world's first patented laser-based breast imaging system which utilises state-of-the-art laser technology and proprietary and patented algorithms to create three-dimensional cross sectional images of the breast.

The 3D imaging technique used is unique to the CTLM system, which is vital to detecting breast abnormalities by providing the radiologist with additional information which may assist with a more precise diagnosis. The CTLM is a non-invasive, painless examination that does not expose the patient to radiation or require breast compression.


Leslie Versweyveld

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