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News We’re Watching: Medicare Prepares To Release TCET, Regulatory Clearances For Medasense and Methinks AI

 
• By Eliza Slawther, Marion Webb, and Elizabeth Orr

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 breakthrough devices programs. Officials from the Centers for Medicare...

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‘Help Us Deregulate’: RFK Announces RFI For Trimming Government Health Agencies

 
• By Brian Bossetta

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MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 
• By Amanda Maxwell

The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.

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