Summary: The average increase in sensitivity for 12 radiologists with the assistance of AccuDetect was 1.5%, which translates into 18.8% increase in the detection of cancers (that were initially missed and only recognized with CAD assistance).
September 4, 2013 - A new computer-aided detection (CAD) solution for digital mammography has received U.S. FDA premarket approval (PMA).
Parascript, LLC announced that its software program, AccuDetect ® 6.1 Computer-Aided Detection system for digital mammography, received PMA and that is indicated for use in screening mammography to identify areas suspicious for breast cancer, for radiologist review, after completing an initial read.
- The FDA granted premarket approval (PMA) of its AccuDetect® 6.1 Computer-Aided Detection (CAD) system for digital mammography.
AccuDetect gives full-field digital mammography (FFDM) system is approved for digital mammography systems manufactured by GE Healthcare and Philips Healthcare. The technology has been proven to lead to a significant increase in effectiveness of radiologists in an enriched retrospective reader study. Based on a 2012 clinical reader study of digital-only images conducted by independent CRO, the average increase in sensitivity for 12 radiologists with the assistance of AccuDetect was 1.5%, which translates into 18.8% increase in the detection of cancers (that were initially missed and only recognized with CAD assistance). Average increase in specificity due to assistance of AccuDetect CAD was 4.9%, which translates into 14.2% decrease in unnecessary recalls (screening studies for which additional diagnostic procedures are recommended).
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 is designed to deliver high performance on dense and extremely dense breasts, in which cancer can be more difficult to detect. In the aforementioned clinical reader study, the system provided the following results on dense breasts: 85% sensitivity, 43% specificity and 1.5 false positives per 4-view study.
AccuDetect can help radiologists to enhance the effectiveness in discriminating between malignant and nonmalignant cases.
For more information: www.accudetect.com and www.appliedradiology.com