News We’re Watching: Medicare Prepares To Release TCET, Regulatory Clearances For Medasense and Methinks AI
A new regulatory agenda from the US Department of Health and Human Services shows that a proposed rule coverage for breakthrough devices is expected in the near future. Additionally, new technology to monitor patent pain during surgery and triage stroke patients got regulatory approvals, and the US FDA added to its webpage on device misconnections.
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A bipartisan group of representatives introduced the Ensuring Patient Access to Critical Breakthrough Products Act of 2023 to provide seniors access breakthrough devices.
Four US representatives sent a letter to CMS urging them to pass a the TCET proposed rule by the end of 2022.
VC funding will remain challenging for many in the health care industry, Silicon Valley Bank’s market manager Milo Bissin told attendees at the recent DHIS West conference. Companies focusing on promising areas such as AI-powered technologies, women’s health and value-based care likely have the best chances to draw investors’ attention.