Allurion has received the US Food and Drug Administration (FDA) clearance for premarket approval (PMA) application for its Gastric Balloon System featuring the Allurion Smart Capsule for obesity treatment.

The Allurion Smart Capsule is protected by more than 50 patents worldwide and is designed to be swallowed in a 15-minute office visit without endoscopy, anaesthesia, or surgery.

Filled with fluid once inside the stomach, it remains there for around four months to help promote satiety and reduced food intake. After this period, a release valve activates, and the capsule is naturally excreted. A subsequent capsule can be administered two months post-passage of the first.

Allurion reported that US obesity rates affect over 100 million people, with nearly 80 million qualifying within a body mass index (BMI) range of 30 to 40 kg/m², the approved indication for this system.

Outside the US, over 200,000 patients have received the Smart Capsule. In commercial use abroad and combined with the Virtual Care Suite, data demonstrates 14% total body weight loss after one cycle and over 20% after two cycles.

Allurion’s programme integrates the FDA-approved Gastric Balloon System with its Virtual Care Suite, which includes a consumer app featuring Iris AI, provider insights dashboard, and a connected scale.

Allurion founder and CEO Dr Shantanu Gaur said: “Today’s approval is a watershed moment for Allurion and for obesity care in the US. 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 US.”

In November 2024, Allurion launched the AllurionMeds GLP-1 programme, an AI-supported monitoring platform and drug dispensary service.