FDA Breakthrough Device designation granted for AI-based mammogram analysis tool
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WashU Medicine Jul 30 2025 A new technology that harnesses AI to analyze mammograms and improve the accuracy of predicting a woman's personalized five-year risk of developing breast cancer has received Breakthrough Device designation from the Food and Drug Administration (FDA). Developed by researchers at Washington University School of Medicine in St. Louis, the software has been licensed to Prognosia Inc., a WashU startup company. The system analyzes mammograms to produce a risk score
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