Obesity Firm Allurion Preps For Global Expansion, US Trial With Changes At Top
Intragastric balloon-maker Allurion is making some major changes in its executive suite to support its plan to expand its market reach.
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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.
The US agency published a final rule on 16 April that says eight medical software functions will no longer be classified as medical devices. The rule finalizes a statutory provision from the 21st Century Cures Act.
The agency has rescinded two previous notices issued by HHS, stating the FDA had no input on the notices before they were published and the rationale backing them was flawed.