Mammography biopsy developer Biopsys of Irvine, CA, announcedlast week that the Food and Drug Administration has accepted itsplan to resolve the agency's concerns about labeling of the company'sMammotome biopsy device. The FDA was concerned about
Mammography biopsy developer Biopsys of Irvine, CA, announcedlast week that the Food and Drug Administration has accepted itsplan to resolve the agency's concerns about labeling of the company'sMammotome biopsy device. The FDA was concerned about marketingmaterials for Mammotome that suggested that the device could beused for therapeutic applications, such as complete excision ofsuspicious breast lesions (SCAN 2/19/97).
As part of the resolution, Biopsys on Feb. 12 submitted a new510(k) application for Mammotome indicating that the product isspecifically intended for breast biopsy for diagnostic purposes.Biopsys will be able to continue selling Mammotome while the FDAreviews the new 510(k).
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.