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Federal Register notice: FDA makes available a final guidance entitled Breakthrough Devices Program.[ Price : $8.95]
CDRH develops a Digital Health Frequently Asked Questions Web page to help developers bring innovative technologies to market.[ Price : $8.95]
FDA clears a Beacon Biosignals 510(k) for the Dreem 3S, a wearable headband with integrated machine learning algorithms to capture...[ Price : $8.95]
FDA approves GlaxoSmithKlines NDA Ojjaara (momelotinib) for treating intermediate or high-risk myelofibrosis.[ Price : $8.95]
FDA publishes a guidance with its policy on participating in the medical device Voluntary Improvement Program.[ Price : $8.95]
FDA publishes an updated final guidance on the Breakthrough Device program.[ Price : $8.95]
FDA grants Attune Medical a de novo marketing authorization for its ensoETM device and its use to reduce the likelihood of ablatio...[ Price : $8.95]
Federal Register notice: FDA establishes a docket to solicit stakeholder comments to assist the agency in developing a Quality Man...