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FDA Breakthrough Device designation granted for AI-based mammogram analysis tool
ST. LOUIS, MISSOURI, JUL 30 – Prognosia Breast uses AI to analyze mammograms and predicts five-year breast cancer risk 2.2 times more accurately than questionnaires, aiming to reduce late-stage diagnoses.
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FDA Breakthrough Device designation granted for AI-based mammogram analysis tool
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).
·United States
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AI-based breast cancer risk technology receives FDA breakthrough device designation
A new technology that harnesses artificial intelligence (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.
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