Clairity Breast AI Wins FDA Nod for Mammography-Based Cancer Risk Prediction

Clairity has received FDA de novo authorization for Clarity Breast, an AI tool that predicts five-year breast cancer risk from screening mammograms.

Key Details

• Clairity Breast predicts future breast cancer risk using AI analysis of 2D screening mammograms.
• FDA de novo authorization has been granted for the software platform.
• The AI model was trained on 450,000+ mammograms and validated on 77,000 exams with five-year follow-up data.
• Unlike CAD tools, the software provides a risk percentage for patients rather than assisting real-time interpretation.
• Models were developed for diverse populations, addressing historic limitations in risk prediction for non-European ancestry.
• Currently available for Hologic mammography systems, with future plans for multivendor and 3D support.

Why It Matters

This represents a significant advance in leveraging mammogram images beyond immediate diagnosis, opening new avenues for personalized risk assessment in breast imaging. The FDA clearance and focus on diversity in model training mark meaningful steps toward broader clinical adoption and equity.

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