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 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.
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.