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CMS Should Create New Roadmap For Breakthrough Technologies, Trade Group Urges

 
• By Brian Bossetta

The Medical Device Manufacturers Association wants the US Medicare agency to come up with a new rule for implementing a coverage pathway for breakthrough devices by June 2022.

ARROW POINTING ON HIGHWAY
• Source: Alamy

With the Medicare Coverage for Innovative Technologies (MCIT) rule on the block, industry is trying to stop the ax from falling.

The program has been overwhelmingly welcomed by the medical device industry and seen as way of cutting through red tape to get innovative treatments to more patients faster. And in a recent letter to the Centers for Medicare & Medicaid Services (CMS), trade organization AdvaMed urged the agency not to repeal MCIT

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First At-Home Cervical Cancer Screening Tool Gets FDA Clearance

 
• By Elizabeth Orr

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New Treatment For Chronic Facial Pain Could Launch By Fall 2025

 
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NeuroOne is preparing to submit its OneRF Trigeminal Nerve Ablation System to the US FDA for treating trigeminal neuralgia, a chronic facial pain condition. CEO Dave Rosa told Medtech Insight that he expects a possible product launch by fall 2025.

Precision Neuroscience’s FDA Clearance For Core Component Of Brain Implant Expected to Accelerate R&D

 
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Precision’s recent FDA clearance for a core part of its next-generation wireless brain-computer interface system opens the pathway to a safer, more humane BCI for researchers to use compared to higher-risk intracortical arrays, according to BCI expert Naveen Rao.

Edwards Mitral Valve Replacement System SAPIEN M3 Receives CE Mark

 
• By Natasha Barrow

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More from Policy & Regulation

Debate On FDA User Fee Reauthorization Begins To Take Shape

 
• By Elizabeth Orr

A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.

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.