Clairity has raised $43 million in Series B funding to commercialize its FDA-authorized AI platform that predicts breast cancer risk 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 is the first FDA-authorized AI platform that predicts a woman’s five-year risk of breast cancer directly from a routine mammogram. The funding will support U.S. commercialization, partnerships with imaging centers and health systems, and development of Clairity Breast 3D and Clairity Heart, a platform for predicting cardiovascular risk from imaging exams.
“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.”
The company has begun initial rollout to health systems and is expanding its pipeline to include AI-based predictive offerings for other diseases using the same deep learning framework. The funding will also support reimbursement initiatives and partnerships to make Clairity Breast accessible across community imaging centers.
“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.”
