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.
FDA Clears New Features in AI-Powered Mammography Software Suite
October 11th 2024Therapixel’s MammoScreen suite has received 510(k) FDA clearances for a breast density assessment feature and updated software that includes automated pre-reporting, which reportedly expedites reporting of mammography findings.