Device Debuts: BSX's Resonate ICD; SYK's Tritanium C Anterior Cervical Cage; ZBH's Persona Partial Knee; MDT's Concerto 3D Coil
This edition of Medtech Insight's Device Debuts includes Boston Scientific's US launch of the Resonate MRI-compatible ICDs, Stryker's Tritanium C 3D-printed anterior cervical cage, Zimmer Biomet's Persona partial knee, and Medtronic's Concerto 3D peripheral aneurysm coil.
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Global Approvals Analysis: LivaNova, Abbott, Medtronic, Boston Scientific Lead List Of January Cardio Approvals
January brought 23 non-US approvals, including 13 CE marks, according to Medtech Insight's Approvals Tracker. The total for January 2018 also exceeds the 20 non-US approvals recorded a year ago.
The numbers of medical device approvals were up in most regions outside the US and the biggest surge, by percentage, was in approvals from emerging markets and the so-called BRIC countries. It remains to be seen if the trend will continue in 2018, but many companies are already counting on important non-US approvals coming in the next year.
A proposed coverage policy from the US Centers for Medicare and Medicaid Services would not only cover magnetic resonance imaging for patients with an implanted cardiac rhythm management device with an FDA-approved indication for MRI-compatibility, but will also cover MRI in patients with devices without that FDA labeling in certain circumstances.