Ambu has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Ambu aScope Gastro and Ambu aBox 2.
aScope Gastro is said to be the company’s first sterile single-use gastroscope with advanced imaging and design features.
Its launch allows the company to enter the gastroscopy market, which has nearly 20 million procedures a year and typically relies on reusable endoscope systems.
Compared to the current reusable endoscopes, this new solution offers portability, advanced technology and cost-effectiveness.
Ambu stated that the single-use aScope Gastro will provide healthcare systems with support for overcoming staff shortages and reducing waiting lists.
It also provides a solution to cross-contamination risks, particularly in vulnerable patients.
The aBox 2 also includes HD capabilities, which improve image quality.
The two solutions form a combined solution, providing a single-use gastroscope, as well as a reusable display and processor unit.
Following receipt of the FDA approval, Ambu plans to proceed with the commercialisation of the aScope Gastro and aBox 2 in the US.
Ambu CEO Juan Jose Gonzalez said: “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.
“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.”
The company stated that the launch of the aScope Gastro, as well as the aScope Duodeno 1.5 launch, represents its next step in expansion into the gastrointestinal (GI) segment.