Ambu’s aScope 5 Broncho Receives 510(k) Clearance

The FDA has granted 510(k) clearance for Denmark-based Ambu’s aScope 5 Broncho single-use bronchoscopes.

The bronchoscopes feature a new high-resolution camera chip as well as increased maneuverability with a flexible insertion tube and 120-degree rotation.

The portable scopes are designed for use in a wide range of healthcare settings, including operating rooms, intensive care units and emergency rooms.

The company, which received Europe’s CE mark for the aScopeTM 5 Broncho range in May, said plans to commercialize the devices in the U.S. and Europe and are underway.