FDA accepts Imation’s reply to warning
Imation of Oakdale, MN, announced June 11 that the Food and Drug Administration has accepted its plan for dealing with concerns outlined in a warning letter it received from the FDA last month (SCAN 6/10/98). The letter was the result of a
Imation of Oakdale, MN, announced June 11 that the Food and Drug Administration has accepted its plan for dealing with concerns outlined in a warning letter it received from the FDA last month (SCAN 6/10/98). The letter was the result of a scheduled FDA visit in April to Imation's laser printer manufacturing facility, where the agency discovered inadequate links between Imation's documentation systems. In its reply, the company detailed a consistent documentation system that satisfies FDA requirements and clarified the connections between its existing documentation systems.
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.
