Clairity Secures $43M to Advance FDA-Authorised AI Platform for Breast Cancer Risk Prediction

Clairity has raised $43m in Series B funding to accelerate the US commercial rollout of Clairity Breast, the first FDA-authorised platform designed to estimate a woman’s five-year breast cancer risk directly from routine mammograms. The round was led by ACE Global Equity and Santé Ventures, with participation from the Breast Cancer Research Foundation and new investors.

Clairity Breast uses AI to analyse subtle imaging features on screening mammograms that correlate with future cancer risk. Cleared through the FDA’s de novo pathway in June 2025, the platform aims to shift breast cancer care from detection to proactive risk prediction.

The new funding will support deployments across major imaging centres, reimbursement initiatives, and expansion into community settings. Clairity also plans to extend its deep-learning framework to develop predictive tools for other diseases. As AI rapidly advances in medical imaging, the company positions its technology to help move breast cancer care toward earlier intervention and prevention.

17-11-2025