Ambu announces FDA clearance of single-use gastroscope and next-generation display unit

Feb. 8, 2022

Ambu has announced the 510(k) regulatory clearance of the Ambu aScope Gastro and Ambu aBox 2 in the United States.

aScope Gastro is Ambu’s first sterile single-use gastroscope and includes new advanced imaging and design features in a combined solution with next-generation display and processor technology. With HD capabilities, the aBox 2 will set a new benchmark in terms of image quality and will be at the centre of Ambu’s endoscopy ecosystem.

With the launch of aScope Gastro, Ambu enters the gastroscopy segment, where 20 million procedures take place annually with reusable endoscope systems.

The advanced technology, portability, and cost-effectiveness of Ambu’s solution address the current limitations of reusable endoscopes, and it will be an attractive choice for customers looking to perform gastroscopies across a wide range of care settings (including endoscopy unit, OR, ICU, ER, ASC). 

Furthermore, the aScope Gastro will support healthcare systems in their efforts to reduce waiting lists and overcome staff shortages, which have been accentuated since the start of the COVID-19 pandemic. Finally, the sterile offering provides a solution to the growing cross-contamination risks, especially for vulnerable patients.

AMBU release