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Parascript Granted FDA Approval for Mammography Computer-Aided Detection System
Date:9/4/2013

duct 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.

About AccuDetect
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 http://www.accudetect.com and info(at)accudetect(dot)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).

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