FDA clears a Mim Software 510(k) for its deep learning auto-contouring software, Contour ProtgAI.
FDA makes available a draft guidance entitled Select Updates for Peripheral Vascular Atherectomy Devices -Premarket Notification [510(k)] Submissions....
Federal Register notice: FDA seeks consumer organizations interested in participating in selecting voting or nonvoting consumer representatives to ser...
Federal Register notice: FDA seeks comments on a new information collection for data to support cross-center collaboration for social behavioral scien...
Federal Register notice: FDA seeks comments on a new information collection entitled Examination of Secondary Claim Disclosures and Biosimilar Disclos...
Two stakeholders comment to FDA on the agencys public workshop on the evolution of artificial intelligence in radiological imaging.
Washington Legal Foundation supports a petition seeking to block FDA from suppressing the dissemination of pharmacogenomics data.
PhRMA says the FDA Office of Minority Health and Health Equity should work with industry to identify and publicize best practices in building subgroup...