Ambu Receives CE Mark and Japanese Clearance for Gastroscope and Display Unit

Ballerup, Denmark-based Ambu’s single-use gastroscope aScope Gastro has earned a CE mark and Japanese clearance for use in combination with its reusable Ambu aBox 2 display unit.

The sterile, single-use scope, which received FDA clearance in February, can reduce the cross-contamination risks of reusable devices, the company said, adding the portable device will “address an important need for health systems and doctors.”

The company said it expects to launch the product in major markets, including Europe, Australia and Canada, in the coming months.