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.