Prognosia Breast AI Earns FDA Breakthrough Designation for Cancer Risk Prediction

July 30, 2025

Prognosia Breast, an AI-driven mammography tool, receives FDA Breakthrough Device status for improved five-year breast cancer risk prediction.

Key Details

  • FDA granted Breakthrough Device designation to Prognosia Breast, an AI mammography analysis tool.
  • Developed by Washington University School of Medicine experts.
  • Tool predicts five-year breast cancer risk from mammogram findings.
  • Claims to be twice as accurate as current risk assessment methods.
  • Aims to inform decisions on supplemental imaging and genetic testing.

Why It Matters

FDA's recognition accelerates the path for advanced AI-enabled risk assessment in breast cancer screening. Improved prediction can enhance early intervention and personalisation, potentially reducing morbidity and mortality.

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