Startup Clairity scored a green light from the FDA for the agency's first artificial intelligence tool designed to predict five-year breast cancer risk from a routine screening mammogram.
According to the company, the FDA’s de novo clearance paves the way for Clairity to launch the risk prediction platform with leading health systems through 2025.
Current commonly used screening methods focus on detecting existing cancer in breast tissue, and most traditional risk models rely on risk factors including age and family history to guide patient follow-up, according to the company.
The platform, called Clairity Breast, analyzes the mammogram itself. The platform uses AI to analyze subtle imaging features on screening mammograms that correlate with future breast cancer risk. The result is a validated five-year risk score delivered to healthcare providers through existing clinical infrastructures, according to the company, which supports more personalized follow-up care.
Clairity says the AI model behind Clairity Breast was trained on millions of images and validated across more than 77,000 mammograms from five geographically distinct screening centers—including hospital-based and freestanding facilities—that collectively serve a diverse patient population, with validation anchored in five-year outcome data.
Each year, more than 2.3 million new cases of breast cancer are diagnosed worldwide, including over 370,000 cases in women in the U.S., according to data from the American Cancer Society. Research indicates that 85% of women diagnosed with breast cancer have no family history, and nearly half have no identifiable risk factors.
Clairity was founded in 2020 by Connie Lehman, M.D., a professor of radiology at Harvard Medical School and a breast imaging specialist at Massachusetts General Hospital.
“For more than 60 years, mammograms have saved lives by detecting early-stage cancers. Now, advancements in AI and computer vision can uncover hidden clues in the mammograms—invisible to the human eye—to help predict future risk,” Lehman said in a statement. “By delivering validated, equitable risk assessments, we can help expand access to life-saving early detection and prevention for women everywhere.”
The company notes that the AI-powered platform is not intended to replace or to be used as the sole determinant for clinical decision-making, and its output is intended to be considered after the radiologist has completed the interpretation of the screening mammogram.
“What makes the availability of Clairity Breast a true sea change is that we’re now predicting risk of future cancer from patterns in breast tissue, in an otherwise normal screening, before it’s even there,” said Jeff Luber, CEO of Clairity, in a statement. “Clairity Breast is designed to fit seamlessly into the current clinical infrastructure to help providers scale precision prevention—with the goal of reducing late-stage diagnoses, lowering costs, and saving more lives.”
Personalized, risk-based screening is critical to improving breast cancer outcomes, noted Robert A. Smith, Ph.D., senior vice president of early cancer detection science at the American Cancer Society.
“By integrating AI models that assess individual risk, we can better identify women at higher risk, and those who may benefit from supplemental screening methods, such as MRI, improving early detection and more effective prevention strategies," he said.
The FDA has cleared other AI-powered tools for breast cancer detection, but Clairity marks the first platform that received a green light for predicting five-year risk from mammograms.
Clairity is backed by Santé Ventures and ACE Global Equity. In January, the startup pocketed a $1 million investment from the Breast Cancer Research Foundation.