OUS Approvals: Cardiovascular Devices Lead Modest List In July
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.
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Medtronic's revenue of $7.1bn for the second fiscal quarter of 2018 was down 4% year-over-year on an as-reported basis, but up 4% on a comparable constant-currency basis. –It would have been even greater if not for the hurricane that hindered manufacturing operations in Puerto Rico, the company reported Nov 21.
Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial announcements, initiations, completions, and suspensions each month. This edition includes entries from a variety of companies and technologies, including many post-market studies following regulatory approvals.
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.