2015-07-29 20:15:19 UTC
July 29, 2015
ReShape Dual Balloon is the 4th obesity device to be approved by the FDA.
The U.S. FDA has just approved the newest tool in the fight against obesity — ReShape Dual Balloon. This non-invasive device, delivered via the mouth through a 30-minute endoscopic procedure, takes up room in the stomach and triggers a feeling of fullness to jump start weight loss.
The AGA Center for GI Innovation and Technology is committed to supporting the development of new devices and their introduction to the market in a safe and efficient manner. The center has been working with the FDA for the past several years to help the agency determine how to assess obesity devices.
“It is gratifying to see that the FDA continues to facilitate technologies to address significant public health concerns,” said chair of the center, Michael L. Kochman, MD, FACP, AGAF. “The AGA Center for GI Innovation and Technology’s obesity-focused meeting, held in conjunction with the FDA, and the annual AGA Tech Summits have helped inform the discussion surrounding the new and novel devices in the obesity and metabolism space.”