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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.

J&J Has Big Plans For Robotic Surgery In 2020

The company’s leadership discussed its recent investments in robotic surgery technology during Johnson & Johnson’s 2019 fourth-quarter earnings call on 22 January. The company will provide more information on its robotic surgery platforms at its investors meeting in May in New York.

NANS 2020: Medtronic’s DTM Spinal Cord Stimulation Relieves Back Pain In Trial

Three-month results from a 94-patient randomized trial of Medtronic’s Intellis spinal cord stimulation system showed superior back-pain relief with the differential target multiplexed waveform compared to conventional spinal cord stimulation.

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