Parascript LLC, an image analysis and pattern recognition technology provider, announced FDA premarket approval (PMA) of its AccuDetect 6.1 Computer-Aided Detection (CAD) system for digital mammography.
AccuDetect is indicated for use in screening mammography to identify areas suspicious for breast cancer, for radiologist review, after completing an initial read.
The software works by using complimentary algorithms and patented voting method to help radiologists more accurately detect cancers while lowering the incidence of patients sent for unnecessary diagnostic workups.
AccuDetect gives Full Field Digital Mammography (FFDM) system manufacturers a next-generation CAD technology option to help radiologists increase cancer detection rates and lower patient recalls. AccuDetect is approved for digital mammography systems manufactured by GE Healthcare and Philips Healthcare. The technology has been shown to lead to a significant increase in effectiveness of radiologists in an enriched retrospective reader study.
AccuDetect delivers very high performance on dense and extremely dense breasts, in which cancer can be more difficult to detect. In a study* the system provided the following results on dense breasts: 85% sensitivity, 43% specificity and 1.5 false positives per four-view study.
