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一次性设备研发商Ambu宣布一次性胃镜获得FDA批准

Ambu earns FDA clearance for single-use gastroscope

Becker's ASC Review 等信源发布 2024-04-09 21:30

可切换为仅中文


Ambu earned FDA clearance for its aScope Gastro Large and Ambu aBox 2, the company said in an April 8 news release.The aScope Gastro Large has a 4.2mm working channel and is designed for acute therapeutic procedures in the ICU. It also can be used for procedures outside the endoscopy unit such as  surgical gastroscopies.The gastroscope is the first single-use device of its kind with a 4.2mm working channel and the first endoscope made with bioplastics..

Ambu在4月8日的新闻发布会上表示,其aScope Gastro Large和Ambu aBox 2获得了FDA的批准。aScope Gastro Large有一个4.2mm的工作通道,专为ICU的急性治疗程序而设计。它也可以用于内窥镜检查单元之外的程序,例如外科胃镜检查。胃镜是同类产品中第一个具有4.2mm工作通道的一次性设备,也是第一个由生物塑料制成的内窥镜。