Parascript has received US Food and Drug Administration approval for its AccuDetect 6.1 computer-aided detection (CAD) system, which helps radiologists improve finding breast cancer.
AccuDetect, which uses artificial intelligence, patented image analysis and pattern recognition technologies, helps radiologists read digital mammograms and improve decision quality in medical imaging.
It is tuned to work with the full-field digital mammography (FFDM) by helping radiologists in the early detection of breast cancer during mammography screening exams.
It is also approved for digital mammography systems manufactured by GE Healthcare and Philips Healthcare.
By using complimentary algorithms and patented voting method, AccuDetect helps radiologists in accurate detection of cancers, especially in discriminating between malignant and non-malignant cases.
The system showed 85% sensitivity, 43% specificity and 1.5 false positives per four-view study in a recent study.
Parascript president and chief technology officer Alexander Filatov said: "We have developed a product that can help radiologists 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 helps radiologists increase cancer detection rates and lower patient recalls through its next-generation CAD technology option.
It also boosts patient care as it lowers the incidence of unnecessary diagnostic procedures and medical expenses related to unnecessary recalls.
AccuDetect is currently being used commercially in European countries such as Austria, France, Germany and Spain.
The FDA has approved the system based on results of a comprehensive clinical reader study, conducted according to recently introduced FDA guidelines which require scientific evidence that radiologists are significantly more effective when they use CAD.