SECOND LOOK ™
ICAD, INC.Second Look™ is a computer-aided detection system used in mammography screening. It digitizes standard mammogram films, analyzes them using AI algorithms to identify suspicious areas like clusters of microcalcifications and masses, and provides marked printouts (Mammagraph™) to assist radiologists in detecting breast cancer more accurately, reducing missed cases while minimally increasing unnecessary work-ups.
Intended Use
The Second Look™ computer-aided detection system for mammography is intended to identify and mark regions of interest on standard mammographic views to bring them to the attention of the radiologist after the initial reading has been completed, assisting in minimizing observational oversights that may warrant a second review.
Technology
The device digitizes mammogram films using a laser-based digitizer, and applies image processing and pattern recognition algorithms hosted on a personal computer to detect potential suspicious areas including clusters of microcalcifications and masses. Detected suspicious areas are marked on a printed Mammagraph™ output to assist radiologists.
Performance
Performance testing included extensive validation on over one thousand mammograms with known malignancies and normal cases, showing effective detection of microcalcifications and masses. Clinical studies (ROSE-1 and ROSE-2) demonstrated a significant reduction in false negatives by at least 26.2% and a clinically insignificant increase in work-up rates by radiologists. The system showed over 99% reproducibility and high sensitivity (85%) for screen-detected cancers.
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