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.

"News We're Watching" Feature Image — • Source: Medtech Insight

The US Department of Health and Human Services plans to issue a proposed rule on Transitional Coverage for Emerging Technologies (TCET) in the near future, the agency said in a regulatory agenda issued on 21 February. The HHS issues regulatory agendas periodically to spotlight upcoming key actions.

TCET is the government’s latest attempt to ensure Medicare coverage for innovative devices cleared through the Food and Drug Administration’s...