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.
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March 18th 2025While recalls initiated by one of two reviewing radiologists after screening mammography were nearly 10 percent higher than recalls initiated by an AI software, the AI-initiated recalls had an 85 percent higher positive predictive value for breast cancer, according to a new study.
ECR Mammography Study: Pre-Op CEM Detects 34 Percent More Multifocal Masses than Mammography
February 28th 2025In addition to contrast-enhanced mammography (CEM) demonstrating over a 90 percent detection rate for multifocal masses, researchers found that no significant difference between histological measurements and CEM, according to study findings presented at the European Congress of Radiology.
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