林业发展局为美国肥胖成人批准了一个非外科减重装置,即Allurion 吞食胃气球。 The FDA approved the Allurion swallowable gastric balloon, a non-surgical weight-loss device, for U.S. adults with obesity.

食品和药物管理局批准了Allurion的可吞胃气球系统,这是美国第一个针对肥胖成人的非外科、无麻醉重量损失装置(BMI 30-40)。 The FDA has approved Allurion’s swallowable gastric balloon system, the first non-surgical, anesthesia-free weight-loss device in the U.S., for adults with obesity (BMI 30–40). Allurion 智能胶囊被吞服后，在胃中膨胀，并停留四个月后自然排出。 The Allurion Smart Capsule is swallowed, expands in the stomach, and remains for four months before naturally passing. 它通过促进充分性和减少食物摄取,帮助减轻体重。 It aids weight loss by promoting fullness and reducing food intake. 批准的依据是临床试验数据显示体重严重减重,4个月内体重减幅高达14%,以及真实世界证据。 Approval was based on clinical trial data showing significant weight loss, with up to 14% body weight loss in four months, and real-world evidence. 该设备与生活方式治疗同时使用,正在全美国推广,并接受医生培训。 The device is used alongside lifestyle therapy and is being rolled out across the U.S. with physician training.