Ambu Receives FDA Clearance for Single-Use Gastroscope and Next-Generation Display Unit

Ambu (Copenhagen, Denmark) has received 510(k) regulatory clearance from the US FDA for the Ambu aScope Gastro and Ambu aBox 2, a combined solution featuring a single-use gastroscope with a reusable display and processor unit.

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. 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

With the launch of aScope Gastro, Ambu enters the gastroscopy segment, where 20 million procedures take place annually with reusable endoscope systems. Together with the launch of the aScope Duodeno 1.5, the aScope Gastro represents the next step in Ambu’s expansion into the GI segment. They will be followed by the next generation single-use duodenoscope (aScope Duodeno 2.0), a colonoscope and a cholangioscope, giving Ambu the most comprehensive single-use portfolio in GI.

“Gastroscopy is not only one of the largest segments in endoscopy, but also has all the conditions to benefit from single-use endoscopy. There is a clear need for more convenience, flexibility, and infection control, which are all addressed with the introduction of our aScope Gastro,” said Juan Jose Gonzalez, CEO of Ambu. “The technology in our aScope Gastro and aBox 2 will set a new benchmark in terms of image quality and functionality and will power all of our next-generation launches. Our expansion within GI will extend Ambu’s position as the world’s most innovative single-use endoscopy player.”

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