Epitomee weight-loss capsule cleared by FDA for sales in US market

18 Sep 2024 — The US FDA has cleared Epitomee Medical’s capsule to support weight management in adults with a Body Mass Index (BMI) of 25–40 kg/m2 alongside diet and exercise. The novel, drug-free, ingestible medical device provides a new option for health-conscious people in the US. 

The Epitomee Capsule is encased in a standard-size, self-administered ingestible capsule. Once it’s swallowed and reaches the stomach, it absorbs water and creates a three-dimensional matrix to occupy volume in the stomach, resulting in a “sensation of fullness,” enabling weight loss.