Allurion Technologies revealed that it’s received U.S. Food and Drug Administration approval of its premarket approval (PMA) application for the Allurion gastric balloon system, which features the Allurion Smart Capsule.

The Allurion Smart Capsule, covered by over 50 patents globally, is swallowed in a 15-minute office visit without needing surgery, endoscopy, or anesthesia. It’s filled with fluid once inside the stomach and remains inside for about four months. During that time, it occupies space in the stomach to help patients feel full and eat less.

After about four months, the Release Valve opens and the capsule passes out of the body naturally. Another Smart Capsule can be swallowed two months after the first passes.

Rather than medications that must be administered daily or injected weekly, Allurion’s approach results in about four months of treatment from one administration.

“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 AUDACITY FDA pivotal trial. “The AUDACITY trial results coupled with the real-world experience outside the United States demonstrate the product’s safety and efficacy. 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. As a standalone or complementary tool to fight obesity, Allurion has an important role to play for both patients and physicians.”

Outside the U.S., the Smart Capsule has already been deployed to treat more than 200,000 patients with results reported in over 30 peer-reviewed medical journal publications.

“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 (ASMBS). “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.”