FDA
FDA clears swallowable gastric balloon for non-surgical weight management
FDA has cleared Allurion’s premarket application for its Gastric Balloon System, a swallowable Smart Capsule designed to support weight management in adults with obesity. The decision was supported by the AUDACITY (NCT05368259) open‑label, randomized study of 550 participants. In the trial, 58% of treated patients achieved more than 5% total body weight loss at 48 weeks (p=0.0089), and weight loss exceeded that of controls, including a 4.22% mean difference at 40 weeks. Serious adverse events occurred in 3.1% of subjects.
The capsule is swallowed during a brief office visit, filled with fluid to occupy gastric volume for about four months, and then naturally expelled via a patented release valve; a second capsule can be given after the first passes. The device requires no surgery, endoscopy, or anesthesia.
Sources:
(2026, February 23). Allurion Receives U.S. FDA Approval [News release]. https://investors.allurion.com/news/news-details/2026/Allurion-Receives-U-S--FDA-Approval/default.aspx
(2026, January 8). Allurion Announces Positive Topline Results From AUDACITY Trial [News release]. https://investors.allurion.com/news/news-details/2025/Allurion-Announces-Positive-Topline-Results-From-AUDACITY-Trial/default.aspx