OUS Approvals Analysis: IVDs Lead A Slow Month
Only 10 approvals from outside the US were recorded in May in Medtech Insight's approvals tracker. Half of those were for in vitro diagnostics, including three for companion diagnostic for cancer drugs.
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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.
Device Debuts: Medtronic MiniMed 670G HCL Insulin Pump; OrbusNeich Sapphire Coronary Balloons; Shockwave Lithoplasty; DePuy Synthes' Fenestrated Spine Screws; Philips Monitoring And Imaging Systems
This edition of Medtech Insight's Device Debuts covers the innovative devices introduced into commercial markets since mid-May, including Medtronic's long-awaited launch of the MiniMed 670G Hybrid Closed Loop insulin pump system, OrbusNeich's entry into the US coronary dilation catheter market, and Shockwave's Lithoplasty system for treating calcified peripheral arteries.
The global medtech industry has a new leader, after a bulked-up Medtronic knocked Johnson & Johnson off its throne. But astute M&A deals, as well as divestments and knock-on impact from poor sales and negative currency effects, have also led to other movements in the medtech company rankings. Medtech Insight's 2016 edition of its annual league tables – MTI 100 and the Top 10 sector leaders – show who's climbed up and who's slipped down.