OUS Approvals Analysis: Medtronic, MicroPort Lead August's Line-Up Of International Approvals
There were 16 CE marks and seven medical device approvals in regions outside of the US and EU in August, according to Medtech Insight's Approvals Tracker. Although 23 approvals in a month is below average for the 2017 OUS tracker, it's more than appeared in August 2016 or 2015, and keeps 2017 on track for 351 approvals from outside the US.
You may also be interested in...
The first quarter of 2018 brought 90 approvals from outside the US, including 56 in Europe, according to Medtech Insight's Approvals Tracker. The biggest category of approvals was cardiovascular, with several new drug-eluting stents and heart-valves coming through during the first three months of the year. Check out our infographic spotlighting the Q1 trends.
The global market for minimally invasive weight loss devices is expected to grow to $290m by 2021, a CAGR of 16%, driven in large part by the rising obesity epidemic and associated Type 2 diabetes. Meddevicetracker expects that enhancements and innovations, particularly in the growing intragastric balloon market, and emerging technologies by smaller companies, will lead the growth in the overall weight loss devices market. In this feature, we'll take a closer look at the overall market and regional landscape and take a deep dive into the fastest-growing intragastric balloon segment, providing key insights from a bariatric surgeon on the pros and cons of these technologies.
Malaysia's conformity assessment-based system for medical devices will finally come into effect at midnight on June 30 2016. That is less than two weeks away, and 'there will be no extension,' says Sasikala Devi Thangavelu, director of the policy, code and standard division of the Malaysian Medical Device Authority1.