The obesity treatment landscape continues to diversify beyond GLP-1 drugs and bariatric surgery.
Allurion Technologies has received FDA premarket approval (PMA) for its Allurion Gastric Balloon System, marking a significant regulatory milestone for non-surgical, device-based obesity care in the U.S. The approval positions the company to compete in a rapidly evolving market increasingly defined by minimally invasive, tech-enabled solutions.
What Makes It Different?
Unlike traditional gastric balloons that require endoscopic placement and removal, the Allurion Smart Capsule is:
- Swallowed in a brief (15-minute) office visit
- Delivered without surgery, endoscopy, or anesthesia
- Designed to remain in the stomach for ~4 months
- Self-emptying and naturally expelled
- Eligible for repeat administration two months after passage
The company describes the system as an AI-powered solution for weight loss, aiming to deliver four months of therapy from a single device—contrasting with daily or weekly GLP-1 injections.