Clairity Receives FDA Approval for AI-Powered Breast Cancer Risk Prediction Tool

The U.S. Food and Drug Administration (FDA) has granted De Novo authorization to Clairity for its CLAIRITY BREAST platform.

This innovative technology uses mammogram images to predict a woman’s five-year risk of developing breast cancer, offering a new approach to early detection and personalised care.

The company plans to introduce the platform through leading health systems across 2025, marking a significant step forward in precision medicine for breast cancer.

Studies indicate that 85% of women who are diagnosed with breast cancer do not have a family history of the disease, and almost 50% present no identifiable risk factors.

Many existing models are also based on limited population data, mainly from European Caucasian women, and do not perform well across diverse racial and ethnic groups.

CLAIRITY BREAST aims to address these gaps by analysing subtle features in mammogram images that may indicate future cancer risk—features that are not visible to the human eye. 

The platform delivers a five-year risk score directly to healthcare providers using existing systems, enabling more personalised and timely follow-up care.

By using artificial intelligence and computer vision, CLAIRITY BREAST offers an alternative to conventional models. 

It helps identify individuals at higher risk who may benefit from additional screening methods such as MRI. This can improve early detection and help prevent more advanced disease.

The tool is designed to integrate easily into current clinical workflows, supporting a move towards more targeted, risk-based screening.