Global Device Approvals, Weekly Snapshot: Hemodialysis Stent, Spine Device, Bleeding Monitor
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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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 FAST 01 feasibility trial is evaluating a modification to Varian’s ProBeam particle accelerator that enables ultra-high dose radiation to treat cancer.
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.