EU Certifies Software That Assesses Short-term Breast Cancer Risk

EU Certifies Software That Assesses Short-term Breast Cancer Risk
ProFound AI Risk, a diagnostic tool that estimates the risk of breast cancer over a two-year period following a mammogram, has received a CE mark from the European Commission. The CE mark is a certification for products sold in the European Economic Area to indicate the product has met all legal standards, and has been evaluated to meet all safety, health, and environmental regulations. "The CE Marking of this technology is a significant milestone that represents the Company’s continued efforts to globally commercialize leading-edge solutions that are positioned to enhance patient care and improve outcomes,” said Stacey Stevens, president of iCAD, which developed the software, in a press release. The ProFound AI technology utilizes a computer algorithm that incorporates data from a mammogram screening, as well as risk factors such as age and breast density, to predict the risk of breast cancer for individual patients. As 2D mammograms are the primary method used to screen women for breast cancer in Europe, the ProFound AI Risk software builds upon that to provide short-term risk assessment. Research has shown that ProFound AI Risk can improve a clinician's ability to evaluate the short-term risk of breast cancer better than previously utilized models, which tend to focus on five- or 10-year risk estimates. "ProFound AI Risk offers a more ho
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