Clairity, an AI-driven precision health company, has raised $43 million in Series B funding to commercialize its FDA-authorized Clairity Breast platform, designed to predict a woman’s five-year risk of breast cancer directly from a routine mammogram. The financing will also support the development of Clairity Breast 3D and Clairity Heart, the company’s next offering aimed at predicting cardiovascular risk using the same imaging data.

“With FDA authorization in hand and commercial partnerships underway, Clairity Breast is poised to redefine how the world approaches breast cancer,” said Jeff Luber, president and CEO of Clairity. The platform is designed to enable earlier interventions, reduce late-stage diagnoses, and support personalized risk-based screening strategies.

The Series B round was led by ACE Global Equity and Santé Ventures, with participation from the Breast Cancer Research Foundation and other new investors. Funding will accelerate U.S. commercialization, expand partnerships with imaging centers and health systems, and advance reimbursement initiatives to improve accessibility across community clinics.

“For decades, we have relied on mammography to detect cancer only after it is visible,” said 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. This is the future of breast cancer care: predictive, personalized, and preventive.”

The company plans to extend the AI-based predictive framework into other major diseases, leveraging its deep learning models to assess risk for cardiovascular conditions and potentially additional conditions in the future. Investors highlighted the unique combination of regulatory validation, clinical impact, and scalable technology as a key factor supporting the financing round.

“Our fundraising is about more than capital; it’s about momentum,” added Luber. “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’s platform represents one of the first FDA-authorized AI tools for breast cancer risk prediction, marking a milestone in the adoption of AI-driven diagnostics to support precision medicine and preventive care.