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CMS Proposes New TCET Pathway, But How Much Difference Will It Make?

 
• By Hannah Daniel

While many industry groups have praised the introduction of TCET, a replacement for the repealed MCIT rule, a Washington Analysis expert has his doubts.

Hearing aids on Medicare Healthcare card.
• Source: Shutterstock

The Center for Medicare and Medicaid Services has released a plan to cover breakthrough devices during a transition period while they await full coverage. Senior Healthcare analyst and vice president of Washington Analysis John Leppard is “skeptical” that this proposal will have a remarkable impact on device coverage.

The Transitional Coverage for Emerging Technologies (TCET) rule replaces a former breakthrough device coverage rule, the Medicare Coverage of Innovative Technologies (MCIT), which was repealed in 2021

The big idea is still the same: TCET is a pathway for the expedited coverage of devices designated as breakthroughs by the US Food and Drug Administration

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Health Secretary Defends Spending Cuts During Senate Hearing On HHS Budget

 
• By Elizabeth Orr

Health and Human Services Secretary Robert F. Kennedy Jr. emphasized administrative cost reductions and defended budget decisions during a Senate hearing on HHS funding. Some senators, however, expressed concerns over the impacts spending cuts had on essential health programs.

Tariffs Threaten Medtech Innovation And US Position As World Leader, Whitaker Tells Lawmakers

 
• By Brian Bossetta

During his testimony before US senators on the impact of tariffs on critical supply chains, AdvaMed’s Scott Whitaker said the Trump tariffs could jeopardize America’s preeminence in medtech. Other industry experts echoed similar concerns.

Califf Warns Progress May Be In Danger Due To ‘Decimated’ FDA Staff

 
• By Barnaby Pickering

In Vivo spoke to the previous commissioner of the US FDA about recent ongoings at the agency, and where he believes policy should be directed for patient and industry benefit.

What’s A Diagnostic? WHO Wants To Know

 
• By Elizabeth Orr

The World Health Organization is seeking input from stakeholders to create an official definition of the term ‘diagnostics.’ This initiative follows a 2023 resolution aimed at enhancing global diagnostics capacity; the definition, it is hoped, will help drive the creation of effective health policies. Comments will be accepted until 23 May.

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LSX Europe: Women’s Health Education Is The Key For Unlocking VC Investment

 
• By Natasha Barrow

Flo Health was the first femtech unicorn to be valued at over $1bn. But the company faced 49 investment rejections before reaching that status, Anna Klepchukova, the company’s chief medical officer, told the LSX World Congress Europe. THENA Capital’s Esther Reynal de St Michel Richardot talked through the firm’s gender-smart investment strategy.

Synchron And Apple Team Up To Use ‘Mind-Thought Connection’ To Control iPhones, iPads

 
• By Marion Webb

Apple and Synchron are teaming up to develop technologies that will one day allow people who can’t use their hands or voice to control iPhones, iPads and other Apple devices by using only their thoughts.

Abbott’s FreeStyle Libre CGM Reduces Cardiovascular Disease-Related Hospitalization

 
• By Natasha Barrow

The REFLECT studies showed a 78% reduction in cardiovascular disease-related hospitalization for people living with type 1 diabetes with prior low blood sugar episodes.