The U.K. Medicines and Healthcare Products Regulatory Agency reported June 24 it joined a global regulatory network for AI that is part of the Health AI regulatory initiative – a program that will invite another nine regulatory agencies to take part in the initiative in the months ahead.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 23andMe, 2MG Medical, Carmat, Catheter Precision, Endo Tools, Fujifilm Holdings, Intershunt, Spectral AI, Toby, Verge Medical.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Empnia, Path AI.
The U.S. Supreme Court preserved the U.S. Preventative Services Task Force coverage mandate that requires payers to cover certain preventive services at no cost to patients in a 6-3 ruling. That’s very good news for many diagnostics companies including Exact Sciences Corp. and Guardant Health Inc. as well as companies that manufacture HIV pre-exposure prophylaxis (PReP) medications such as Gilead Sciences Inc.
The U.K. National Health Service may or may not deploy transcatheter aortic valve replacement devices as widely as in the U.S., but the National Institute for Health and Care Excellence officially staked out the position the data are not yet compelling for anyone other than high risk patients.
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