The regulatory approval in the EU, announced yesterday, comes five years after the system’s FDA clearance in the U.S.

With a CE mark, Audubon, Pennsylvania–based Globus kicks off commercialization of Excelsius3D in the European Union and United Kingdom. According to Globus Medical, Excelsius3D expands the Excelsius ecosystem on the continent. The offerings, which also include the ExcelsiusGPS robotic navigation system, are for spine and cranial surgeries.