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

 
• By David Filmore and Reed Miller

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.

Approved

Three novel device or indication approvals were added to Medtech Insight's Approvals Tracker last week, including Vertos Medical Inc.'s mild device kit to treat lumbar spinal stenosis.

The mild system, which has been 510(k)-cleared in the US for more than a decade and gained Medicare coverage in 2016, is now CE marked for use in Europe and other regions. (Also see "Medicare Slightly Expands Coverage For Spine Procedure, But Policy Remains Trial-Limited" - Medtech Insight, 14 December, 2016

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