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Medicare Slightly Expands Coverage For Spine Procedure, But Policy Remains Trial-Limited

 
• By Reed Miller

Vertos Medical asked the US Medicare agency to reconsider its 2014 decision that limits coverage of percutaneous image-guided lumbar decompression for lumbar spine stenosis to certain clinical trials. The agency ruled Dec. 7 that it will stick with the trial-limited policy, but expanded it to include longitudinal studies.

The US Centers for Medicare and Medicaid Services is maintaining its coverage-with-evidence-development (CED) approach to percutaneous image-guided lumbar decompression (PILD) for lumbar spinal stenosis, but will expand the coverage policy to include longitudinal studies. CMS issued its National Coverage Analysis decision memo for the PILD procedure Dec. 7.

In 2014, CMS agreed to cover PILD for patients enrolled in an approved clinical trials that meet certain criteria. (Also...

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NICE To Consult On UK Late-Stage Healthtech Assessments

 
• By Ashley Yeo

NICE’s three-pronged lifecycle approach to healthtech evaluations includes late-stage assessments (LSA), which will be the focus of a short consultation in August.

FDA ‘Regulatory Accelerator’ Aims To Speed Digital Health Development

 
• By Elizabeth Orr

The US FDA has launched the Regulatory Accelerator to expedite digital health product development. This includes resources like a Resource Index for Innovators, a Medical Device Software Guidance Navigator, and best practices for early meetings.

From ‘Work Harder’ to ‘Phenomenal People’: Makary’s FDA About-Face

 
• By Michael McCaughan

In his first 100 days as FDA commissioner, Martin Makary has gone from vocal critic to vocal supporter of the agency’s staff, calling them “phenomenal” and praising their dedication—even as morale remains shaken by recent layoffs and restructuring.

Time For Medtech To Have Its Say On Critical Changes In EU Framework Legislation

 
• By Amanda Maxwell

In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.

More from Medtech Insight

FDA ‘Regulatory Accelerator’ Aims To Speed Digital Health Development

 
• By Elizabeth Orr

The US FDA has launched the Regulatory Accelerator to expedite digital health product development. This includes resources like a Resource Index for Innovators, a Medical Device Software Guidance Navigator, and best practices for early meetings.

From ‘Work Harder’ to ‘Phenomenal People’: Makary’s FDA About-Face

 
• By Michael McCaughan

In his first 100 days as FDA commissioner, Martin Makary has gone from vocal critic to vocal supporter of the agency’s staff, calling them “phenomenal” and praising their dedication—even as morale remains shaken by recent layoffs and restructuring.

Execs On The Move: July 14–18, 2025

 
• By Medtech Insight Team

An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.