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.