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Swallowable Capsule Gets FDA Green Light for Weight Loss
24 Feb
Summary
- FDA approves Allurion's Smart Capsule for obesity treatment.
- The capsule is swallowed and remains for four months.
- It offers an alternative to GLP-1s and bariatric surgery.
Allurion's Smart Capsule has received FDA clearance for its Gastric Balloon System, marking a significant advancement in obesity treatment within the United States. This innovative capsule is designed to be swallowed during a brief office visit, requiring no endoscopy, anesthesia, or surgery.
Once ingested, the capsule fills with fluid, aiding satiety and reducing food consumption for approximately four months. Afterward, it naturally passes from the body, with a subsequent capsule deployable two months post-passage. This program aims to offer a safe and effective weight loss solution.
Dr. Shantanu Gaur, Allurion's founder and CEO, highlighted the approval as a "watershed moment," positioning the Smart Capsule as a viable alternative to GLP-1s and bariatric procedures. The system integrates with Allurion's Virtual Care Suite, including an AI-powered app and provider dashboard.
This development arrives as obesity rates soar, with over 100 million people affected in the US. The approved indication targets nearly 80 million individuals with a BMI between 30 and 40 kg/m². Internationally, over 200,000 patients have utilized the Smart Capsule, demonstrating significant weight loss.
