U.S. Surgical of Norwalk, CT, has received an updated 510(k) clearancefor its ABBI breast biopsy system, which had been the subjectof Food and Drug Administration scrutiny last year (SCAN 6/19/96).FDA regulators claimed that ABBI's original 510(k) did
U.S. Surgical of Norwalk, CT, has received an updated 510(k) clearancefor its ABBI breast biopsy system, which had been the subjectof Food and Drug Administration scrutiny last year (SCAN 6/19/96).FDA regulators claimed that ABBI's original 510(k) did not allowthe company to market the device for breast biopsy applications,while U.S. Surgical claimed that it included breast biopsy datain the submission. The new 510(k), issued last month, resolvesthe dispute.
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.