BOSTON, Mass. — Clairity, Inc., an AI-driven precision health company specializing in image-based risk prediction, has closed a $43 million Series B financing round to support the commercialization of Clairity Breast, the first FDA-authorized artificial intelligence platform that predicts a woman’s five-year risk of breast cancer using a routine mammogram. The funding will also advance the development of Clairity Breast 3D and Clairity Heart, the company’s next AI offering designed to predict cardiovascular risk from the same standard imaging exam.
The financing round was led by ACE Global Equity and Santé Ventures, with continued participation from the Breast Cancer Research Foundation and several new investors. The investment reflects broad confidence in Clairity’s mission to enable earlier intervention, reduce late-stage diagnoses, and expand its predictive platform into additional areas of population health.
The new capital will accelerate U.S. commercialization, expand partnerships with leading imaging centers and health systems, and support the build-out of Clairity’s broader pipeline of predictive health tools. Following FDA authorization and initial deployments at major health systems, the company is preparing for broader national rollout and pursuing reimbursement pathways to make Clairity Breast accessible across community imaging sites.
“For decades, we have relied on mammography to detect cancer only after it is visible,” said Connie Lehman, MD, PhD, 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. This is the future of breast cancer care: predictive, personalized, and preventive.”
“Our fundraising is about more than capital; it’s about momentum,” said Jeff Luber, Clairity’s President and CEO. “With FDA authorization in hand and commercial partnerships underway, Clairity Breast is poised to redefine how the world approaches breast cancer. 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.”
“BCRF has long believed that prevention is the ultimate cure,” said Donna McKay, President and CEO of the Breast Cancer Research Foundation. “Clairity’s technology embodies that vision, turning existing imaging infrastructure into a proactive tool for risk stratification toward earlier interventions that can save lives. We’re proud to continue supporting their work as they bring this innovation to women everywhere.”
“Santé is proud to support Clairity in advancing a new era of predictive breast health,” said Kevin Lalande, Founding Managing Director and Chief Investment Officer of Santé Ventures. “By pairing clinically validated AI with scalable access channels, Clairity exemplifies the type of innovation that can help drive better outcomes for patients and greater cost efficiency across the healthcare system.”
“Clairity’s work represents exactly the kind of innovation we need in healthcare, where data and AI move us from reacting to disease to preventing it,” said Joe Kiani, Founder and Executive Chairman of Willow Laboratories, and Founder of Masimo (NASDAQ: MASI). “By transforming routine imaging into a window of prediction, Clairity empowers physicians and patients alike to act earlier, which should lead to better outcomes.” Mr. Kiani has joined Clairity as an investor and board member.
TCB Capital Advisors served as the exclusive financial advisor to Clairity for the Series B financing.
