The Food and Drug Administration has released a draft versionof rules intended to guide manufacturers through the regulatoryreview process for full-view digital mammography devices (SCAN9/13/95). The guidelines cover several areas, including a
The Food and Drug Administration has released a draft versionof rules intended to guide manufacturers through the regulatoryreview process for full-view digital mammography devices (SCAN9/13/95). The guidelines cover several areas, including a draftprotocol for a clinical study to demonstrate the agreement interms of effectiveness between digital and analog mammographyfor screening applications, as well as a draft protocol for aclinical study to establish the sensitivity, specificity and othercharacteristics of screening digital mammography. The FDA is requestingthat interested parties submit their comments on the draft guidelinesto the agency by Oct. 30.
Study: Mammography AI Leads to 29 Percent Increase in Breast Cancer Detection
February 5th 2025Use of the mammography AI software had a nearly equivalent false positive rate as unassisted radiologist interpretation and resulted in a 44 percent reduction in screen reading workload, according to findings from a randomized controlled trial involving over 105,000 women.