The U.K.'s Medicines and Health Care Products Regulatory Agency chose five technologies for its AI Airlock pilot program as it looks to understand the best way to regulate artificial intelligence-powered medical devices so that they can be safely deployed across the national health service.
At long last, the U.S. FDA finalized guidance on using predetermined change control plans in submissions for medical devices that include artificial intelligence. The guidance, “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions,” aims to support the iterative improvement central to many algorithms while minimizing potential issues with safety and efficacy.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Carlsmed, Rhein Laser, Zimmer Biomet.
In breaking news, Wave Neuroscience LLC received breakthrough device designation from the U.S. FDA for its magnetic electroencephalogram resonance therapy for adjunctive treatment of post-traumatic stress disorder (PTSD), making its technology the first medical device approved to treat the debilitating condition, the company said.
New hires and promotions in the med-tech industry, including: Adapthealth, Delfi Diagnostics, Hyperfine, Second Heart Assist, Transmedics Group, Vitrolife.
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