Global Approvals Analysis: Emerging Markets Drive Volume Of OUS Approvals
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.
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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.
Earnings Winners & Losers: ABMD, BSX, EW, ABT Pump Money Into Cardio; SYK, ZBH Innovate Ortho Surgery
Most of the major medical device companies have reported sales and earnings for the last three months of 2017 and the full year. Cardiovascular companies are succeeding with new technology while continuing to grow revenues from established technologies, especially in emerging markets. Orthopedic firms are looking to new technology, like surgery robots and neurostimulation, to differentiate themselves from the competition and improve profits.
2017 was another record year for novel device approvals in the US, with typical large numbers of cardiovascular and IVD go-aheads, along with notable successes in neurology, with noninvasive stimulation and digital-app solutions seeing success. There was also an increase in 510(k) clearances last year. Here's a look at some key FDA approvals and clearance trends from the past year, including in infographic form.