1. Medtech Insight

News We’re Watching: TCET Pathway Announced, QSMR Final Rule Date Announced, Vitang Dental Aligner Post-Approval Changes

 
• By Hannah Daniel

CMS publishes a long-awaited proposal for coverage of breakthrough devices, the Office of Information and Regulatory Affairs confirmed a December 2023 release date for the final QMSR rule, and dental technology company Vitang Technology LLC is accused of violating QSR standards.

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

The Center for Medicare and Medicaid Services has announced the publication of its highly anticipated Transitional Coverage for Emerging Technologies rule. The rule is scheduled to be released on 27 June.

TCET, which industry has been waiting for since the repeal of the Medicare Coverage for Innovative Technology (MCIT) rule in late 2021, will provide five years of reimbursement coverage for...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Policy & Regulation

More from Medtech Insight

TRiCares Tricuspid Valve Replacement System Reduces Regurgitation In First-In-Human Study

 
• By Natasha Barrow

TRiCares presented data from the first-in-human study for its tricuspid valve replacement system – Topaz – at EuroPCR 2025 on 22 May.

Swiss Medtechs Advised To Work On US Tariff Mitigation Strategies

 
• By Ashley Yeo

The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.

Guardant Health Launches Germline Hereditary Cancer Test

 
• By Natasha Barrow

Guardant Health introduces a new germline panel test to help guide cancer treatment, assess the risk of secondary cancers in patients and identify family members at risk of cancer.