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.

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

To avoid a wider health equity gap for home-use devices, companies should make social determinants of health a key consideration in device development, former nurse Amy Hester says.

This week, MHRA and NICE released results from their first survey of potential digital health tool users; the FDA warned against using Getinge/Marquet cardiac devices; and Illumina announced plans to hand its Grail spin-off to existing shareholders.

After clarifying what a remanufactured device is in its 2021 draft guidance, FDA’s final guidance adds information about regulatory requirements for companies whose devices qualify as remanufactured.

In this episode, Medtech Insight senior reporter Hannah Daniel speaks to Mark Brown, Global Managing Director of Digital Trust Consulting at the British Standards Institute about digital trust. In a world of cybersecurity breaches and ransomware attacks on hospitals, digital trust between companies and consumers is key, but current siloed operations can hinder that. We talk about the EU’s AI act, the speed of digital transformation, cybersecurity incentives, and how principle-based regulations are better than prescriptive ones.