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.
“We are committed to bringing innovative enabling technologies to surgeons around the world, and this important milestone further expands the capabilities of our platform by combining intraoperative imaging with the robotic navigation capabilities of ExcelsiusGPS across the European Union,” Globus Medical CEO Keith Pfeil said in a news release.
Excelsius3D combines 3D cone-beam computed tomography (CT), 2D fluoroscopy, and digital radiography in a single system. The company says it easily integrates with ExcelsiusGPS. Excelsius3D’s compact footprint and omnidirectional wheels are meant to enable easier positioning and transport within the operating room.
“Excelsius3D was developed with a focus on bringing advanced imaging capabilities into a mobile platform that can integrate within the surgical workflow,” said Globus Medical CTO Norbert Johnson. “Its integration with ExcelsiusGPS represents an important step in connecting imaging, navigation, and robotics within the Excelsius ecosystem, providing surgeons with complementary technologies designed to work together throughout the surgical workflow.”
