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news.GI Dynamics, a medical device company, has received the European CE mark approval for the EndoBarrier, its novel, noninvasive device currently in clinical trials to treat obesity and Type 2 diabetes. The company has also received ISO certification for its Lexington facility.
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Stuart Randle, CEO of GI Dynamics, said: “We are very pleased to announce that we have received both the ISO certification and the CE mark approval, which are important milestones as we continue to develop the EndoBarrier and lay the groundwork for future commercialization of the product.
“Promising data continue to emerge from our clinical development programs in both obesity and type 2 diabetes, and we look forward to conducting larger, longer-term trials with the EndoBarrier in the year ahead.”