US Approvals Analysis: April A Big Month For Non-Invasive Neurostim
Two de novo go-aheads granted by FDA last month sent non-implantable neurostimulation devices to market, one for headaches and the other for tear production. Overall, the agency granted four de novos in April, continuing a strong trend this year for that marketing pathway, according to Medtech Insight's Approvals Tracker.
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July 2017 brought 26 approvals from outside the United States, including 14 CE marks in Europe and 12 from five other territories. Almost half of the approvals were for cardiovascular devices; the rest came from eight other categories.
Approvals of neurostimulation and cardiology devices dominated the list of non-US medtech approvals in June. According to Medtech Insight's Approvals Tracker, there were 36 medtech approvals outside the US last total that month, including 28 CE marks in Europe, plus approvals from China, Canada, Australia/New Zealand and Brazil.