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Global Device Approvals, Weekly Snapshot: Hemodialysis Stent, Spine Device, Bleeding Monitor

Executive Summary

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, Vertos Medical gains a CE mark for its spine stenosis procedure kit, and US approvals for BD and Saranas.

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

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.

Varian Launches Trial Of Flash Ultra-High Dose Radiotherapy

The FAST 01 feasibility trial is evaluating a modification to Varian’s ProBeam particle accelerator that enables ultra-high dose radiation to treat cancer.

Three Studies Support Medtronic’s Cryoablation Systems As ‘First Line’ AFib Treatment

Data from the EARLY AF First, Cryo-FIRST and STOP AF trials show cryoablation is a better option than drugs for patients with symptomatic atrial fibrillation.

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