FDA mulls over breast cancer ablation registry
The FDA is considering a national registry for thermal ablation treatment of breast cancer. The proposed registry would compile information on all thermal ablation devices and therapies for small carcinomas and address inconsistencies that potentially diminish the value of previously published feasibility protocols.
The FDA is considering a national registry for thermal ablation treatment of breast cancer. The proposed registry would compile information on all thermal ablation devices and therapies for small carcinomas and address inconsistencies that potentially diminish the value of previously published feasibility protocols. It would also lay out standard protocols for tumor selection, biopsy techniques, pathology studies, image guidance, and postablation assessment.
The FDA described its rationale for a registry in the May 28 Federal Register. It will accept comments on the plan until Nov. 28.
Considering Breast- and Lesion-Level Assessments with Mammography AI: What New Research Reveals
June 27th 2025While there was a decline of AUC for mammography AI software from breast-level assessments to lesion-level evaluation, the authors of a new study, involving 1,200 women, found that AI offered over a seven percent higher AUC for lesion-level interpretation in comparison to unassisted expert readers.
Contrast-Enhanced Mammography and High-Concentration ICM Dosing: What a New Study Reveals
June 16th 2025New research showed a 96 to 97 percent sensitivity for contrast-enhanced mammography (CEM) with an increased iodine delivery rate facilitating robust contrast enhancement for women with aggressive breast cancer.
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.
