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2001 DEC 27 - (NewsRx.com & NewsRx.net) -- CADx Medical Systems, a subsidiary of Shire Pharmaceuticals Group, PLC, (SHP.L, SHPGY, SQ), has received an approvable letter from the U.S. Food and Drug Administration (FDA) for its Second Look computer-aided detection (CAD) system for mammography.
Second Look is a screening tool that provides radiologists with a computerized second review of mammograms. The system utilizes breakthrough technology to highlight potential areas of concern on a mammograph report, calling attention to subtle changes in tissue that may indicate the presence of cancer. After viewing mammograms, the radiologists refer to the mammograph to assist in their final decision for the most appropriate course of treatment.
The approvable letter applies to the Premarket Approval (PMA) application for Second Look, ...
Source: HighBeam Research, CADx Medical Systems Receives FDA Approvable Letter For Second...