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
- 1Clairity Breast predicts future breast cancer risk using AI analysis of 2D screening mammograms.
- 2FDA de novo authorization has been granted for the software platform.
- 3The AI model was trained on 450,000+ mammograms and validated on 77,000 exams with five-year follow-up data.
- 4Unlike CAD tools, the software provides a risk percentage for patients rather than assisting real-time interpretation.
- 5Models were developed for diverse populations, addressing historic limitations in risk prediction for non-European ancestry.
- 6Currently available for Hologic mammography systems, with future plans for multivendor and 3D support.
Why It Matters

Source
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