The Food and Drug Administration this month granted premarket notification clearance to a new 510(k) application filed by Biopsys Medical of Irvine, CA, for its Mammotome breast biopsy device. Biopsys filed the new 510(k) application on Feb. 12 as part
The Food and Drug Administration this month granted premarket notification clearance to a new 510(k) application filed by Biopsys Medical of Irvine, CA, for its Mammotome breast biopsy device. Biopsys filed the new 510(k) application on Feb. 12 as part of an agreement with the FDA to resolve labeling issues regarding Mammotome (SCAN 3/5/97). The agency's move allows Biopsys to market Mammotome for diagnostic breast biopsy applications.
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.