Key Points:
- Ambu receives FDA clearance for aScope Gastro Large, the world’s first single-use therapeutic gastroscope.
- The device features a 4.2mm working channel and expands Ambu’s portfolio for upper GI procedures.
- It addresses diverse clinical needs across ICUs, ORs, and endoscopy suites.
- Designed for acute therapeutic procedures like bleeding management and food impaction, as well as complex endoscopic procedures like necrosectomy and stenting.
- Offers enhanced suction performance compared to existing therapeutic gastroscopes.
- Made with bioplastic materials, reducing the device’s carbon footprint.
- FDA clearance follows European regulatory approval (CE mark) obtained in September 2023.
- Ambu’s single-use gastroscope portfolio demonstrates high completion and satisfaction rates for EGD and is effective in evaluating and treating upper GI bleeding.