Allurion Technologies
Allurion Technologies said the FDA has granted it premarket approval (PMA) for its Gastric Balloon System featuring the Allurion Smart Capsule.
The Allurion Smart Capsule is swallowed during an office visit without the need for surgery, endoscopy, or anesthesia. It's filled with fluid once inside the stomach, and resides inside for approximately four months. During that time, it occupies space within the stomach, helping patients feel full and eat less.
After approximately four months, the patented release valve opens, and it passes out of the body naturally.
Outside the United States, the company said the Allurion Smart Capsule has already been deployed to treat more than 200,000 patients.
