September 4, 2013 Longmont, CO – Parascript®, LLC, the image analysis and pattern recognition technology provider, today 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.
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 breakthrough technology has been proven to lead to a significant increase in effectiveness of radiologists in an enriched retrospective reader study*. 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 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 percent sensitivity, 43 percent specificity and 1.5 false positives per four-view study.
AccuDetect can help radiologists to enhance the effectiveness in discriminating between malignant and non-malignant cases, and boosts patient care by helping radiologists to simultaneously increase the chance of finding a cancer and reduce the chance of unnecessary diagnostic procedures. As a result, patients may experience reduced anxiety and lower medical expenses due to fewer unnecessary recalls.
“We are very excited to have obtained FDA approval for AccuDetect. Our vision has always been to build the world’s best CAD product for mammography,” said Alexander Filatov, Parascript’s president and chief technology officer. “We believe we have achieved that, and have developed a product that can help radiologists to increase both sensitivity and specificity at the same time. We look forward to working with mammography equipment manufacturers and radiologists to help them improve the standard of care in mammography.”
AccuDetect is currently being used commercially in Spain, France, Germany and Austria. It achieved FDA approval based on results of a comprehensive clinical reader study.* The study was conducted according to recently introduced FDA guidelines which require scientific evidence that radiologists are significantly more effective when they use CAD.
AccuDetect is a product of Parascript, LLC. Employing artificial intelligence, patented image analysis and pattern recognition technologies, AccuDetect helps radiologists read digital mammograms and improve decision quality in medical imaging. Parascript draws on over 15 years of providing high-value image analysis and recognition solutions. Fortune 500 companies and major government and financial institutions rely on Parascript software. Learn more about AccuDetect at www.accudetect.com and email@example.com.
*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 percent, which translates into 18.8 percent 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 percent, which translates into 14.2 percent decrease in unnecessary recalls (screening studies for which additional diagnostic procedures are recommended).