Clairity: $43 Million Series B Raised To Advance FDA-Authorized AI Platform For Breast Cancer Risk Prediction

By Amit Chowdhry ● Yesterday at 5:20 PM

Clairity, the Boston-based precision health company developing AI-driven risk prediction tools from standard medical imaging, has raised $43 million in Series B funding to accelerate commercialization of its flagship product and expand into new disease areas. The round was led by ACE Global Equity and Santé Ventures, with additional participation from the Breast Cancer Research Foundation and several new investors.

The funding supports the commercial rollout of Clairity Breast, the first FDA-authorized artificial intelligence platform that predicts a woman’s five-year breast cancer risk directly from a routine mammogram. It will also advance Clairity Breast 3D and Clairity Heart, a forthcoming cardiovascular risk prediction tool built on the same deep learning foundation. The company plans to scale U.S. market adoption, broaden partnerships with imaging centers and major health systems, and strengthen reimbursement initiatives aimed at nationwide availability.

Clairity has already begun deploying its technology across multiple large health systems following FDA authorization. The Series B financing positions the company to expand its portfolio into new predictive offerings for major diseases by extracting risk insights from existing imaging infrastructure. Leadership and investors emphasized that this approach represents a shift from traditional detection to preventive, precision-based care.

Support: TCB Capital Advisors served as the exclusive financial advisor on the transaction.

KEY QUOTES:

“With FDA authorization in hand and commercial partnerships underway, Clairity Breast is poised to redefine how the world approaches breast cancer.”

“For decades, we have relied on mammography to detect cancer only after it is visible. 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.”

Connie Lehman, MD, PhD, Founder of Clairity

“Our fundraising is about more than capital; it’s about momentum. 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.”

Jeff Luber, President and CEO, Clairity

“Clairity represents a rare combination of scientific rigor, regulatory validation, and transformative clinical impact. Predictive imaging is the next frontier in oncology, and Clairity Breast is the first real-world embodiment of that promise.”

Gabriella Antici, Partner and Chief Investment Officer, ACE Global Equity

“BCRF has long believed that prevention is the ultimate cure. 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.”
Donna McKay, President and CEO, Breast Cancer Research Foundation

“Santé is proud to support Clairity in advancing a new era of predictive breast health. 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.”

Kevin Lalande, Founding Managing Director and Chief Investment Officer, Santé Ventures

“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. By transforming routine imaging into a window of prediction, Clairity empowers physicians and patients alike to act earlier, which should lead to better outcomes.”

Joe Kiani, Founder and Executive Chairman of Willow Laboratories; Founder of Masimo; Investor and Board Member at Clairity

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