Clairity secures $43 million to roll out FDA-authorized AI breast cancer risk tool

Investing.com -- AI-driven precision health company Clairity has raised $43 million in Series B funding to commercialize its FDA-authorized breast cancer risk prediction platform.

The funding round was led by ACE Global Equity and Santé Ventures, with participation from the Breast Cancer Research Foundation (BCRF) and several new investors.

Clairity Breast is the first FDA-authorized AI platform that predicts a woman’s five-year risk of breast cancer directly from routine mammograms. The company will use the new capital to accelerate U.S. commercialization, expand partnerships with imaging centers and health systems, and continue developing its broader predictive health platform.

The funds will also support the development of Clairity Breast 3D and Clairity Heart, which aims to predict cardiovascular risk from the same imaging exams.

"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."

Jeff Luber, Clairity’s President and CEO, noted that with FDA authorization secured and commercial partnerships underway, the company is "poised to redefine how the world approaches breast cancer."

The financing will also support reimbursement initiatives aimed at making Clairity Breast accessible across community imaging centers nationwide.

Joe Kiani, Founder of Masimo (NASDAQ:MASI), has joined Clairity as an investor and board member. TCB Capital Advisors served as the exclusive financial advisor for the Series B financing.

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