Clairity Breast is the first FDA-authorized AI platform that predicts a woman’s five-year future risk of developing breast cancer, using only her existing screening mammogram.
Until now, screening methods only detect cancer in breast tissue once visible, and most traditional risk models rely on risk factors including age and family history to guide patient follow up.
While mammography screening is the best tool we have for early detection, there are common challenges of false positives, false negatives, human variation in image interpretation and lack of access to specialized radiologists.
Each year, over 2.3 million new cases of breast cancer are diagnosed worldwide, including over 370,000 cases in women in the United States.
And while family history and age inform traditional risk models, 85% of women diagnosed with breast cancer have no family history and nearly half of newly diagnosed women have no identifiable risk factors.
The AI platform behind Clairity Breast was trained across millions of mammogram images, matched with five-year outcome data, to identify patterns in breast tissue that correlate with future cancer development.
The Clairity Breast software device is intended to generate a 5-year risk prediction of breast cancer based on a bilateral screening mammogram. Clairity Breast provides a prediction of the percentage probability that the individual will receive a diagnosis of breast cancer or develop breast cancer within the 5-year timeframe following the screening mammogram, through analysis of mammography features and characteristics.
Eligible patients do not have a known breast cancer at presentation for their screening mammogram.
Clairity Breast is not intended to diagnose or detect breast cancer, or to provide care recommendations. Clairity Breast is not intended to replace or to be used as the sole determinant for clinical decision-making. Clairity Breast output is intended to be considered after the radiologist has completed the interpretation of the screening mammogram.
Clairity Breast analyzes full-field digital mammograms or directly acquired 2D images from Hologic Lorad Selenia® and Selenia® Dimensions® Mammography Systems; it does not analyze synthetic 2D images.
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Most risk assessment models rely on age and family history however, 85% of women diagnosed with breast cancer have no family history and nearly half of newly diagnosed women have no identifiable risk factors. Clairity Breast relies only on the screening image to determine the five-year breast cancer risk.
The AI model behind Clairity Breast was trained across millions of mammogram images, matched with five-year outcome data, to identify patterns in breast tissue that correlate with future cancer development.
Clairity Breast does not detect or diagnose cancer. It predicts a five-year future risk, potentially enabling high-risk patients to prioritize early preventive interventions and more effective screening strategies, shifting the focus from reactive diagnosis to proactive prevention and enhanced screening.
Clairity Breast has officially launched in Massachusetts, and we are preparing to launch in Colorado in April 2026. As we continue to expand, we’ll keep you updated on new state launches and important milestones.
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Connie Lehman, founder and CEO of Clairity, shares how AI-driven insights can improve early detection, personalize screening, and ultimately change the future of breast-cancer care.
In this episode of the SBI podcast, host Dr. Karla Sepulveda welcomes Connie Lehman, MD, PhD to discuss how artificial intelligence is transforming breast cancer risk assessment. Dr. Lehman explains how AI-powered analysis of mammograms can identify women at elevated risk who may be missed by traditional risk models, paving the way for more personalized screening strategies. She also shares the story behind the development of the Mirai model and Clarity Breast, discusses recent NCCN guideline updates incorporating AI-based risk assessment, and explores the potential impact on screening recommendations, equity, and patient care.
In a new study published in Radiology, BCRF investigator Dr. Connie Lehman, founder of Clairity Breast and professor of radiology at Harvard Medical School, and colleagues found that AI-detected signals can change over time, producing a dynamic risk score that evolves and offers insight into long-term risk.
