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This edition of Quick Notes looks at news in the medical device industry with Medtronic exiting the ventilator market, an FDA warning letter for a nasal spray, and FDA clearances for the first robotic assistant for shoulder surgery and an electrophysiological home monitor system. Read More
Over the past week, the FDA issued a final rule adding the Digital Health Advisory Committee to the list of standing committees, final guidance on COVID-19 symptoms in clinical trial subjects, and draft guidance on medical device user fees for small businesses. Read More
While three of the companies warned of inappropriate Orange Book patent listings by the FTC are delisting all the challenged patents, according to the U.S. legislators who led the action, five others refused to delist. Read More
AdvaMed has published seven “foundational” principles to guide innovations, policymaking and regulation in AI and machine learning (ML) for medtech as part of an information blitz that includes an overview paper and a list of AI facts and myths. Read More
Smartwatches and smart rings that claim to measure blood glucose levels without piercing the skin have not been authorized, cleared or approved by the FDA, the agency has warned in a recent safety communication. Read More
Small medical device manufacturers who are experiencing financial hardship — and are in an active bankruptcy — can look to a new FDA draft guidance for information on how to become eligible for a waiver of their registration fee. Read More
The General Accountability Office (GAO) should press the FDA to stop being passive in its oversight of device safety and instead take a more bold and active role, according to several academicians who collaborated on an opinion piece in the peer-reviewed healthcare journal Health Affairs. Read More