FDA approved the Allurion Gastric Balloon System on February 20 under P250023. The label covers adults 22 to 65 with a BMI of 30 to 40 who have failed at least one weight-loss program. Patients can get up to two balloons over 10 months alongside lifestyle therapy. FDA received the PMA on June 30, 2025, a 235-day review. Allurion announced the approval on February 23. Product code LTI.
The balloon arrives as a capsule the patient swallows in a 15-minute office visit. It fills, sits in the stomach about four months, then empties and passes on its own, with no endoscopy or anesthesia. AUDACITY randomized 550 patients 1:1. On the responder co-primary endpoint, 58% of balloon patients lost more than 5% of body weight at 48 weeks (p=0.0089). The comparative co-primary missed. The 3.77% mean difference in total body weight loss did not clear the pre-specified 3% superiority margin with significance (p=0.1616). At week 40 the gap had been 4.22%. Serious adverse events ran 3.1%.
Shantanu Gaur and Samuel Levy founded Allurion in Natick, Massachusetts in 2009. It listed on the NYSE as ALUR in 2023 through a SPAC. More than 200,000 patients have used the balloon outside the US. An approval with one co-primary endpoint missed shows the review weighs the whole file. A 3.1% serious adverse event rate in a Class III weight-loss device helped.