Recipient: Patients with heterogeneously dense breasts or extremely dense breasts.
Notification text: Summary of written report that is sent to the patient must include a notice that the patient has dense breast tissue, that this dense breast dense tissue may make it more difficult to detect cancer on a mammogram, and that this dense breast tissue may increase the patient's risk of breast cancer.
Legislation: Mammogram Results
Mammography AI Platform for Five-Year Breast Cancer Risk Prediction Gets FDA De Novo Authorization
June 2nd 2025Through 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.