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