Devices

FDA to Scrutinize AI-Powered Mental Health Devices

FDA has scheduled an 11/6 Digital Health Advisory Committee meeting to examine the rise of generative artificial intelligence (AI) in digital mental health medical devices, signaling heightened concern from the agency about the technology’s risks and regulatory gaps. AI-based mental health devices are increasingly being promoted as tools to expand access to mental health care. With demand for mental health services in the U.S. far outpacing available providers, such devices are being explored as potential solutions to bridge the care gap.

However, FDA officials warn that the technology comes with “novel risks.” As AI systems grow more complex and begin to play a role in diagnosing and treating mental health conditions, regulators face pressure to ensure patient safety without stifling innovation.

FDA says the committee will discuss the “benefits, risks to health, and risk mitigations that might be considered for these new digital mental health devices, including premarket evidence and postmarket monitoring considerations. The committee will weigh the potential benefits of AI-enabled devices against their risks, including concerns about accuracy, bias, misuse, and the adequacy of clinical evidence. Members will also consider what types of premarket evidence should be required and how companies should monitor their products once they are on the market.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome