Clairity has closed a $43 million Series B round to accelerate commercial rollout of its FDA-authorised AI tool that predicts breast cancer risk using standard mammogram images. The investment was led by ACE Global Equity and Santé Ventures, with backing from the Breast Cancer Research Foundation and additional new investors.
Clairity Breast is the first FDA-authorised AI platform designed to estimate a woman’s five-year likelihood of developing breast cancer directly from routine screening images. The latest funding will support expansion across the US, new partnerships with imaging providers and health systems, and further development of Clairity Breast 3D and Clairity Heart, the company’s forthcoming cardiovascular risk prediction product.
“For decades, we have relied on mammography to detect cancer only after it is visible,” said Dr. Connie Lehman, Founder of Clairity. “With Clairity Breast, we can now use the same images to predict who may be at risk over the next five years, supporting earlier intervention, fewer late-stage diagnoses, and more lives saved.”
Initial deployment has already begun within selected health systems, and Clairity is broadening its pipeline to include additional predictive tools for other conditions using its deep learning framework. The new capital will also contribute to reimbursement work and wider accessibility efforts, particularly for community imaging centres.
“With FDA authorization in hand and commercial partnerships underway, Clairity Breast is poised to redefine how the world approaches breast cancer,” said Jeff Luber, Clairity’s President and CEO. “We’re proud to stand at the forefront of a paradigm shift—from detection to prevention—and to deliver technology that empowers women and their doctors to predict risk to support action before cancer starts.”
“Clairity represents a rare combination of scientific rigor, regulatory validation, and transformative clinical impact,” said Gabriella Antici, Partner and Chief Investment Officer at ACE Global Equity. “Predictive imaging is the next frontier in oncology, and Clairity Breast is the first real-world embodiment of that promise.”
