Mammography AI Platform for Five-Year Breast Cancer Risk Prediction Gets FDA De Novo Authorization

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Through AI recognition of subtle patterns in breast tissue on screening mammograms, the Clairity Breast software reportedly provides validated risk scoring for predicting one’s five-year risk of breast cancer.

The Food and Drug Administration (FDA) has granted de novo authorization for the artificial intelligence (AI) powered software Clairity Breast, which can offer five-year assessment of breast cancer risk based on screening mammograms alone.

Validated on more than 77,000 mammograms from multiple hospital-based and free-standing facilities, the Clairity Breast software provides AI assessment of pixel-level imaging data to enhance personalized risk stratification, according to Clairity, the developer of the software.

Mammography AI Platform for Five-Year Breast Cancer Risk Prediction Gets FDA De Novo Authorization

Could the AI-powered Clairity Breast software be a game-changer for mammogram assessment? The software, which recently garnered FDA de novo authorization, can reportedly predict five-year breast cancer risk based on screening mammography alone. (Image courtesy of Adobe Stock.)

Emphasizing the challenges of traditional breast cancer risk screening protocols due to a lack of diversity in training cohorts and a lack of prior family history with the disease in 85 percent of women diagnosed with breast cancer, Clairity said the Clairity Breast offers game-changing potential for facilitating early detection.

“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,” said Connie Lehman, M.D., a professor at Harvard Medical School and the founder of Clairity. “By delivering validated, equitable risk assessments, we can help expand access to life-saving early detection and prevention for women everywhere.”

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