FDA Approves Allurion's Swallowable Gastric Balloon System for Weight Loss

The US Food and Drug Administration has approved Allurion Technologies' premarket approval application for the Allurion Gastric Balloon System, a weight-loss balloon that patients swallow as a capsule, the Natick, Massachusetts company said on February 23 in a press release filed with the SEC as an exhibit to a Form 8-K.

The FDA's premarket approval database lists the decision as P250023, issued on February 20, 2026. The agency received the application on June 30, 2025.

What the FDA approved

According to the approval order statement in the database, the system "is indicated to promote short-term limited weight loss in adult individuals with obesity between the ages of 22 years and 65 years with a body mass index (BMI) greater than or equal to 30 kg/m2 and less than or equal to 40 kg/m2 who have had at least one unsuccessful attempt at a weight loss program." It is to be used with a moderate-intensity lifestyle modification program and consists of up to two balloons placed during a 10-month period, with an average observed residence time of 15.3 weeks per balloon.

Allurion says the capsule is swallowed in a 15-minute office visit without surgery, endoscopy or anesthesia, then filled with fluid to form a balloon in the stomach. After about four months a release valve opens, the balloon empties and it passes out of the body naturally, the company said. A second capsule can be swallowed about two months after the first passes.

The AUDACITY trial

The pivotal AUDACITY study was an open-label, multicenter, randomized controlled trial of 550 participants, assigned 1:1 to two balloon cycles plus care or to moderate-intensity lifestyle therapy alone, HCPLive reported, citing Allurion's topline results.

The trial met its responder co-primary endpoint: 58% of balloon recipients lost more than 5% of total body weight at 48 weeks. The comparative co-primary endpoint missed. The mean difference in total body weight loss between the groups at 48 weeks was 3.77%, which did not meet the prespecified 3% superiority margin (p=0.1616); the report attributed the shortfall in part to greater-than-anticipated weight loss in the control group. At week 40, around when the second balloon passed, the difference was 4.22%.

The rate of serious adverse events among balloon recipients was 3.1%, HCPLive reported, citing the company's results.

Commercial plans

Allurion said about 80 million Americans fall within the approved BMI range and that the capsule has been used to treat more than 200,000 patients outside the United States. Chief executive Shantanu Gaur said in the release: "Today's approval is a watershed moment for Allurion and for obesity care in the United States." The company's release did not give a US launch date or price.