The FDA has granted premarket approval for the Allurion gastric balloon system, a swallowable weight loss device that requires no surgery, endoscopy or anesthesia.
The system, developed by Allurion Technologies, uses a capsule that expands into a balloon in the stomach and self-empties after about four months. A second capsule can be administered two months after the first passes, according to a Feb. 23 news release.
The device is designed for use during a 15-minute office visit and offers a four-month treatment period from a single administration. The company previously paused sales of the device in France before reintroducing it last year. Outside the U.S., it has been used in more than 200,000 patients.
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