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Hannah Daniel

Senior Reporter

Hannah joined Medtech Insight from HBW Insight in August 2022 and reports on cybersecurity, patent law and other facets of medical device regulation. Hannah is passionate about the intersection of science and communication and holds a bachelor’s degree in biology from Carnegie Mellon University.

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This week, an FDA advisory panel recommended approval of the Guardant Shield blood test for colon and rectal cancers; the EU Council signed off on the world’s first AI law; and the FDA challenged innovators to develop AI/ML technologies to detect gait freezing in individuals with Parkinson’s disease

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Device manufacturers still have a low level of cybersecurity maturity, but larger companies seem to be doing better than smaller ones.

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AI regulation experts discussed the pros and cons of AI “nutrition labels” for transparency, international harmonization of AI regulation and – of course—PCCPs at a recent summit.

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News We’re Watching: Telehealth Advances; AI Regulation; NIH Backs SIRT; Oura Upgraded

This week, a House subcommittee advanced a two-year telehealth extension, Chuck Schumer and a bipartisan group of senators introduced a plan for regulating AI, the FDA launched its new online RST Catalog, NIH recommends targeted radiotherapy cancer treatment, and Oura announced new health features for its smart ring.

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Of the 151 AI/ML devices added from August 2023 to March 2024, 117 were radiological devices.

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