Back to all news

Prognosia Breast AI Earns FDA Breakthrough Designation for Cancer Risk Prediction

Prognosia Breast AI Earns FDA Breakthrough Designation for Cancer Risk Prediction

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.
Health Imaging

Source

Health Imaging

View all from this source

Ready to Sharpen Your Edge?

Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.

We respect your privacy. Unsubscribe at any time.