
Prognosia Breast, an AI-driven mammography tool, receives FDA Breakthrough Device status for improved five-year breast cancer risk prediction.
Key Details
- 1FDA granted Breakthrough Device designation to Prognosia Breast, an AI mammography analysis tool.
- 2Developed by Washington University School of Medicine experts.
- 3Tool predicts five-year breast cancer risk from mammogram findings.
- 4Claims to be twice as accurate as current risk assessment methods.
- 5Aims 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.

Source
Health Imaging
Related News

•Radiology Business
RadNet and Desert Oasis Launch No-Cost AI Breast Cancer Screening
RadNet partners with Desert Oasis Healthcare to provide AI-enhanced breast cancer detection at no extra cost.

•Radiology Business
Women's Uncertainty About AI in Breast Imaging May Limit Acceptance
Many women remain unclear about the role of AI in breast imaging, creating hesitation toward its adoption.

•AuntMinnie
Stanford Team Introduces Real-Time AI Safety Monitoring for Radiology
Stanford researchers introduced an ensemble monitoring model to provide real-time confidence assessments for FDA-cleared radiology AI tools.