FDA approves Allurion's Gastric Balloon System under PMA

The FDA has granted premarket approval for Allurion's Gastric Balloon System, which uses a swallowable Smart Capsule designed to remain in the stomach for about four months; the company reports the device has been used in more than 200,000 patients outside the US.

Allurion has received US Food and Drug Administration premarket approval for its Gastric Balloon System, which features the swallowable Allurion Smart Capsule for obesity treatment. The device is intended to be administered in a short office visit without endoscopy, anesthesia, or surgery. Allurion says the system is accompanied by a Virtual Care Suite and that the company launched an AllurionMeds GLP-1 programme in November 2024. Key details: - The FDA granted premarket approval for Allurion's Gastric Balloon System featuring the Smart Capsule, according to the article. - The Smart Capsule is designed to be swallowed in about a 15-minute office visit and does not require endoscopy, anesthesia, or surgery. It is reported to be protected by more than 50 patents worldwide. - Once in the stomach the capsule is filled with fluid, remains for roughly four months to promote satiety, then a release valve activates and the device is naturally excreted; a subsequent capsule can be administered two months after passage of the first. - The article reports that more than 200,000 patients have received the Smart Capsule outside the US, and combined with the Virtual Care Suite the company reports average total body weight loss of about 14% after one cycle and over 20% after two cycles in commercial use abroad. - Allurion reported US obesity affects over 100 million people and that nearly 80 million fall within a BMI range of 30 to 40 kg/m², the article states as the approved indication for the system. Summary: The FDA approval allows Allurion's Gastric Balloon System to be marketed in the United States under its approved indication, and the company presents the Smart Capsule as a non-surgical option paired with digital care tools. Undetermined at this time.