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Parascript Issued FDA Approval for Mammography Computer-Aided Detection System

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Earlier this week, Parascript®, LLC, which is the image analysis and pattern recognition technology provider, announced FDA premarket approval (PMA) of its AccuDetect® 6.1 Computer-Aided Detection (CAD) system for mammography" href="/tag/digital-mammography.html">digital mammography.

AccuDetect is known for its use in screening mammography to identify and distinguish areas suspicious for breast cancer, for radiologist review, after completing a preliminary read.

AccuDetect provides Full Field Digital Mammography (FFDM) system responsible for manufacturering next-generation CAD technologies in order to assist radiologists increase cancer detection rates and lower patient recalls.

AccuDetect has been granted approval for digital mammography systems manufactured by General Electric Healthcare and Philips Healthcare. The standout technology has been proven to lead to a major increase in efficacy of radiologists in a supplemental retrospective reader study. AccuDetect 6.1 Computer-Aided Detection

The software functions by utilizing corresponding algorithms and original voting methods to aid radiologists more accurately detect cancers while lowering the frequency of patients sent for otherwise avoidable diagnostic check ups.

AccuDetect provides high standard performance levels on dense and exceedingly dense breasts, in which cancer can be more challenging to detect.

In a study based on a 2012 clinical reader study of digital-only images conducted by independent CRO, the system delivered the following results on dense breasts: 85 percent sensitivity, 43 percent specificity and 1.5 false positives per four-view study.

AccuDetect can assist radiologists to improve the success in discerning between malignant and non-malignant leisions, and strengthen patient care by enabeling radiologists to concurrently increase the chance of finding a cancer and reduce the chance of pointless 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. 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,” said Parascript’s president and chief technology officer, Alexander Filatov.

AccuDetect is currently being employed commercially in Spain, France, Germany and Austria. It was awarded FDA approval based on the outcomes of a comprehensive clinical reader study in 2012. The study was conducted according to recently introduced FDA guidelines which call for scientific evidence that radiologists are notably more effective when they use CAD.

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