FDA Grants Premarket Approval to Allurion Gastric Balloon System for Weight Loss

The US Food and Drug Administration (FDA) has granted premarket approval (PMA) to the Allurion Gastric Balloon System, which incorporates the Allurion Smart Capsule, for weight loss among those with obesity.1

This February 23 announcement by Allurion Technologies, Inc. highlights the Smart Capsule’s patented technology, noting its intention to be swallowed within a brief, approximately 15-minute office visit. Internationally, the Smart Capsule has been implemented in more than 200,000 patients, the company noted, with data on its use documented in over 30 peer-reviewed medical journals.

“Obesity is a critical issue in the United States, and many patients are looking for alternatives or complements to existing options, including GLP-1 medications,” Shelby A. Sullivan, MD, professor of medicine at the Geisel School of Medicine at Dartmouth University and principal Investigator on the AUDACITY FDA pivotal trial, said in a statement.1

Obesity is known to impact more than 100 million individuals in the US, with roughly 80 million falling within the body mass index (BMI) range of 30 - 40 kg/m².1 In this release, Allurion noted estimates suggesting around 20 million people in the US have initiated and subsequently discontinued GLP-1–based treatments. They also cited projections suggesting this figure may increase to 40 million by 2027.

In previous data, research cited by the Company suggests 65% of patients stop GLP-1 treatment within their initial year of use. This is most often attributed to adverse effects. Many can also experience rapid weight regain following the discontinuation of their use, they added.

To promote weight reduction in such individuals, the Allurion Gastric Balloon System is FDA-approved for short-term reduction among adults aged 22 - 65 years with obesity in the aforementioned BMI range. It is specifically for individuals who previously attempted and did not succeed with at least 1 structured weight loss program.

The Smart Capsule system does not require endoscopy, surgery, or anesthesia. Once the capsule is in a patient’s stomach, it is filled with liquid. It remains in place for about 4 months. Taking up space in the stomach, it promotes earlier satiety and diminishes one’s food intake. Following about 4 months, a proprietary Release Valve opens, leading the deflated device to pass naturally through one’s gastrointestinal tract.

Later, a second capsule may be administered 2 months following the first’s exit from the body. In contrast to anti-obesity medications, which Allurion noted must be received on a daily or weekly basis, a single Smart Capsule can allow for around 4 months of therapeutic effect from a single administration.

The submission of the Allurion Gastric Balloon System to the FDA for consideration followed the product’s successful topline data in the AUDACITY trial.2 The study, an open-label, multicenter, randomized controlled study, involved 550 participants who were randomized 1:1 to be given either 2 cycles of the Allurion Balloon plus care or moderate-intensity lifestyle therapy by itself.

The analysis met its responder co-primary endpoint, with 58% of Allurion Balloon recipients losing more than 5% of their total body weight at the 48-week mark (P = .0089).2 By this point in time, the mean difference in total body weight loss between the cohorts was shown by investigators to be 3.77%, corresponding to a 2.69% superiority margin.

This did not meet its pre-specified 3% margin required for the comparative co-primary endpoint (P = .1616).2 This was attributed in part to greater-than-anticipated weight loss in the control arm of the study. However, by Week 40, around the time the second balloon passed, the AUDACITY investigators noted the mean difference in weight loss as 4.22%, exceeding the 3% superiority threshold.

The reported rate of serious adverse events among those who were Allurion Balloon recipients was noted to be 3.1%.2 This was described as the lowest rate reported in an FDA pivotal trial of a liquid-filled intragastric balloon.

“The AUDACITY trial results coupled with the real-world experience outside the United States demonstrate the product’s safety and efficacy,” Sullivan said in her statement.1,2 “The solution offers an option that many people are looking for. It has a finite time in the body, is repeatable when necessary, and it does not require patients to take long-term medications for weight loss.”

References

1. Allurion Receives U.S. FDA Approval. Allurion Technologies, Inc. February 23, 2026. https://www.businesswire.com/news/home/20260223930098/en/Allurion-Receives-U.S.-FDA-Approval.

2. Allurion Announces Positive Topline Results From AUDACITY Trial. Allurion Technologies, Inc. January 8, 2026. Accessed February 23, 2026. https://investors.allurion.com/news/news-details/2025/Allurion-Announces-Positive-Topline-Results-From-AUDACITY-Trial/default.aspx.