Ambu USA of Columbia has announced the 510(k) regulatory clearance of the Ambu aScope Gastro and Ambu aBox 2. 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 expand our advanced display offering.
With the launch of aScope Gastro, Ambu enters the upper gastrointestinal (GI) segment, where 20 million procedures are performed annually with reusable endoscope systems.
The advanced technology, portability and cost-effectiveness of Ambu’s solution address the current limitations of reusable endoscopes, and will be an attractive choice for customers looking to perform esophagogastroduodenoscopy or upper GI procedures across a wide range of care settings, including the endoscopy unit, operating room, intensive care unit, emergency room and ambulatory surgery centers.
Furthermore, the aScope Gastro will support health care 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 growing cross-contamination risks, especially for vulnerable patients.