NATICK, Mass. — Allurion Technologies has received U.S. Food and Drug Administration approval for its Allurion Gastric Balloon System, clearing the way for the company to offer the treatment to an estimated 80 million Americans living with obesity.
The approval covers the Allurion Smart Capsule, a swallowable gastric balloon designed to promote weight loss without surgery, endoscopy, or anesthesia. The capsule is taken during a brief office visit, filled once inside the stomach, and remains in place for about four months before passing naturally through the body.
“Today’s approval is a watershed moment for Allurion and for obesity care in the United States,” said Dr. Shantanu Gaur, founder and chief executive officer of Allurion. “Our goal is to deliver patients metabolically healthy weight loss by helping them lose weight, keep it off, and maintain muscle. The Allurion Smart Capsule offers a safe and effective alternative to GLP-1s and bariatric surgery, and it should become a standard tool in the comprehensive treatment of obesity in the United States.”
More than 100 million Americans have obesity, according to company estimates, with about 80 million falling within a body mass index range of 30 to 40, the approved range for treatment with the Smart Capsule. Allurion said a growing number of patients have started and stopped GLP-1 medications due to side effects and weight regain, creating demand for alternative or complementary treatment options.
Unlike daily pills or weekly injections, a single Smart Capsule provides about four months of treatment. After the balloon passes, another capsule can be administered following a two-month interval.
“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,” said Dr. Shelby Sullivan, professor of medicine at the Geisel School of Medicine at Dartmouth University and principal investigator on the company’s FDA pivotal trial. “The trial results, coupled with real-world experience outside the United States, demonstrate the product’s safety and efficacy. 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.”
Outside the United States, the Allurion Smart Capsule has been used to treat more than 200,000 patients, with outcomes reported in more than 30 peer-reviewed medical journal publications. In international commercial use, the company said patients achieved an average total body weight loss of about 14 percent when combined with its virtual care program, and more than 20 percent with two treatment cycles. Higher weight loss was also reported when combined with low-dose GLP-1 therapy.
“Allurion’s innovative solution is an important tool within the continuum of obesity care,” said Dr. Jaime Ponce, president and medical director of the Weight Loss Center of Chattanooga and former president of the American Society for Metabolic and Bariatric Surgery. “For patients with a BMI between 30 and 40 seeking meaningful health improvements, the Allurion Smart Capsule could be an attractive option, especially for those seeking a structured alternative to medications or surgery.”
