Clairity has received US Food and Drug Administration (FDA) De Novo authorisation for CLAIRITY BREAST, an artificial intelligence (AI)-driven platform that predicts five-year breast cancer risk from standard screening mammograms.
The company expects this development to influence precision medicine for breast cancer through 2025, with plans for integration into major health systems.
The platform assesses imaging features associated with future breast cancer risk, offering healthcare providers a validated five-year risk score through existing clinical infrastructures. This facilitates personalised follow-up care based on individual risk assessments from routine screenings.
Clairity founder Connie Lehman said: “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.
“By delivering validated, equitable risk assessments, we can help expand access to life-saving early detection and prevention for women everywhere.”
CLAIRITY BREAST, according to its developer, sets a new standard for risk-based screening and preventive strategies. Operating under the name Allix5, it examines mammography data at the pixel level to identify individuals at increased future breast cancer risk.
The AI model is said to have been extensively trained on millions of images and validated across over 77,000 mammograms from various geographic locations.
The software provides a five-year probability of breast cancer following a bilateral screening mammogram but is not used for diagnosis or detection. Its predictions are meant to support rather than replace clinical decision-making.
Eligible patients do not have a known breast cancer diagnosis at the time of their screening mammogram. The system supports radiologists who have completed their interpretations by offering insights that can guide further personalised interventions and screening strategies.
The system analyses full-field digital mammograms from specific hologic devices but excludes synthetic 2D images. By forecasting future risk, CLAIRITY BREAST seeks to prioritise early preventive measures for high-risk patients and shift focus from reactive to preventive care.
