FDAnews
www.fdanews.com/articles/148942-gi-dynamics-gets-fda-ok-for-clinical-trial

GI Dynamics Gets FDA OK for Clinical Trial

August 24, 2012
GI Dynamics announced approval from the FDA to skip the pilot trial usually required for medical devices, allowing the company to move directly into a pivotal clinical trial of its lead product, a device for the treatment of obese patients who have uncontrolled Type 2 diabetes.
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