FDA approves Allurion Gastric Balloon System PMA

Reuters02-23
FDA approves Allurion Gastric Balloon System PMA

Allurion Technologies, Inc. said the U.S. Food and Drug Administration has approved its premarket approval application for the Allurion Gastric Balloon System, which includes the Allurion Smart Capsule. The company said the device is intended for patients with a body mass index range of 30 to 40 kg/m² and is administered in an office visit without surgery, endoscopy, or anesthesia.

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