Allurion Technologies announced that the U.S. Food and Drug Administration granted pre‑market approval for its Gastric Balloon System, featuring the swallowable Allurion Smart Capsule, on February 23, 2026. The approval authorizes the company to begin commercial sales of the procedure‑less intragastric balloon in the United States, targeting adults with a body mass index of 30 to 40 kg/m² and an addressable market of roughly 80 million U.S. adults with obesity.
The approval follows a series of regulatory milestones that culminated in the final PMA module submission, a Day‑100 meeting with no additional data requests, and zero findings in BIMO inspections. These achievements demonstrate the company’s ability to meet the FDA’s stringent safety and efficacy requirements and signal that the product is ready for market entry.
Allurion’s financial performance in the period leading up to the approval has been challenging. Q4 2024 revenue was $5.6 million, and full‑year 2024 revenue totaled $32.1 million, both figures representing a decline from the prior year. The company projected Q4 2025 revenue of $3.3 million to $3.7 million, a significant year‑over‑year drop driven by a reduced product mix and a strategic shift toward a more focused commercial strategy. Management has implemented a hiring freeze and cut non‑essential R&D spend to reduce operating expenses and improve cash flow.
Dr. Shantanu Gaur, founder and CEO, described the approval as a watershed moment for obesity care in the United States. He emphasized that the Smart Capsule offers a safe and effective alternative to GLP‑1 medications and bariatric surgery, and that the company aims to make it a standard tool in comprehensive obesity treatment. The CEO also highlighted the company’s experience treating over 200,000 patients outside the U.S., with reported weight loss of about 14 % after one balloon cycle and over 20 % after two cycles or when combined with GLP‑1 therapies.
The FDA clearance positions Allurion to capture a substantial share of the growing obesity‑treatment market. By removing the final regulatory hurdle, the company can begin scaling its B2B2C obesity‑management platform and pursue high‑margin subscription revenue. However, the company remains mindful of competitive headwinds from GLP‑1 drugs and the need to secure sufficient financing to support ongoing operations and growth initiatives.
The content on EveryTicker is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.