The U.S. Food and Drug Administration (FDA) has approved the first artificial intelligence (AI) tool to predict breast cancer risk.

The authorization was confirmed by digital health tech company Clairity, the developer of Clairity Breast – a novel, image-based prognostic platform designed to predict five-year breast cancer risk from a routine screening mammogram.

In a press release, Clairity shared its plans to launch the AI platform across health systems through 2025.

Most risk assessment models for breast cancer rely heavily on age and family history, according to Clairity.

However, about 85% of cases occur in women who have no family history of breast cancer, likely stemming from genetic mutations that occur because of aging, health agencies report.

Traditional risk model

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