FDA grants PMA approval for Allurion gastric balloon system for obesity

ALLURION TECHNOLOGIES, INC.

Allurion Smart Capsule approved for adults 22-65 with BMI 30-40 kg/m² after unsuccessful weight loss attempt.
Balloon swallowed in 15-min office visit, no surgery/endoscopy/anesthesia; stays ~4 months, then passes naturally.
AUDACITY pivotal trial data supported approval; over 200,000 patients treated outside US with 14% total body weight loss.
Opens access to ~80 million US adults with obesity; alternative to GLP-1s and bariatric surgery.
Company cited 65% GLP-1 discontinuation rate within first year and rapid weight regain as unmet need.

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