FDA approves Allurion’s PMA software for gastric balloon system
Allurion has acquired U.S. Meals and Drug Administration (FDA) approval for a pre-market approval software (PMA) for its Allurion Sensible Capsule gastric balloon system for the therapy of weight problems.
The Allurion Sensible Capsule is protected by greater than 50 patents worldwide and is designed to be swallowed throughout a 15-minute workplace go to with out endoscopy, anesthesia or surgical procedure.
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As soon as stuffed with fluid within the abdomen, it stays there for about 4 months to advertise satiety and cut back meals consumption. After this era, a launch valve is activated and the capsule is excreted naturally. A subsequent capsule could be administered two months after the passage of the primary.
Allurion reported that weight problems charges within the U.S. have an effect on greater than 100 million folks, with almost 80 million eligible inside a physique mass index (BMI) vary of 30 to 40 kg/m2, the accredited indication for this method.
Outdoors the US, greater than 200,000 sufferers have acquired the Sensible Capsule. When used commercially overseas and together with the Digital Care Suite, the information reveals a complete weight lack of 14% after one cycle and over 20% after two cycles.
Allurion’s program integrates the FDA-cleared gastric balloon system with the Digital Care Suite, which features a shopper app with Iris AI, a provider insights dashboard and a related scale.
Allurion Founder and CEO Dr. Shantanu Gaur mentioned, “In the present day’s approval is a turning level for Allurion and for weight problems care within the U.S. Our objective is to supply sufferers with metabolically wholesome weight reduction by serving to them reduce weight, keep weight and keep muscle.
“The Allurion Sensible Capsule offers a protected and efficient various to GLP-1s and bariatric surgical procedure, and will change into a normal device within the complete therapy of weight problems within the US.”
In November 2024, Allurion launched the AllurionMeds GLP-1 program, an AI-enabled drug monitoring platform and pharmacy.
