GI Dynamics revs up anti-obesity device for Brazilian market

Courtesy of GI Dynamics

GI Dynamics is planning a big entry into the massive Brazilian market with its non-surgical device to treat Type 2 diabetes and obesity. And it will use a local distributor to accomplish this: Brazil's CMS Medical. Before that point however, Brazilian regulatory authorities must approve EndoBarrier, and GI Dynamics has that covered, too. The company submitted its registration application for the product to the regulatory agency ANVISA, and a CMS sister company will help manage the regulatory process. If all goes according to plan, EndoBarrier will launch in Brazil in early 2014. Meanwhile, the company is pursuing a U.S. clinical trial for Endobarrier with an eye toward a 2015 FDA regulatory submission. Release

Suggested Articles

The former CEO of the molecular testing company Foundation Medicine, Troy Cox, has been named chairman of the Swiss big data firm Sophia Genetics.

Researchers at MIT used a machine-learning algorithm to uncover the potent antibiotic properties hiding within an old small-molecule candidate.

The randomized, blinded study showed statistically significant improvements in assessments of inattention and brain activity.