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.
Get answers to questions we hear most often
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.
Commercial launch is scheduled for Q4 2025 in the US. Submit the Be the First to Know form to get more information on Clairity Breast when it becomes available.
For the first time, they will receive risk scores revealing their likelihood of developing the disease in the next five years, not based on their genetics or family history, but through features on their mammogram, visible only to an AI tool called Clairity Breast.
Routine mammograms are the mainstay of breast cancer screening. But, with a new type of analysis powered by artificial intelligence, doctors may be able to also predict whether or not you’ll develop breast cancer in the next few years.
About one in eight women will be diagnosed with the disease in their lifetimes. To combat that, some doctors are using AI as a tool to help them not only detect breast cancer, but also predict a woman’s risk factors.
