CE Mark Granted to Globus Medical’s Excelsius3D Imaging System

Globus Medical Inc.’s Excelsius3D intelligent 3-in-1 imaging system has been CE marked for commercial sale in the European Union and the United Kingdom. The addition of Excelsius3D expands the company’s Excelsius Ecosystem of enabling technologies and further enhances the ExcelsiusGPS robotic navigation system’s capabilities in the European Union.

“The CE mark for Excelsius3D represents an important milestone in the continued expansion of the Excelsius Ecosystem,” Globus Medical President/CEO Keith Pfeil said. “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.”

Excelsius3D is an intelligent, mobile imaging platform that combines 3D cone-beam computed tomography (CT), 2D fluoroscopy, and digital radiography in a single system. Designed for intraoperative use, Excelsius3D seamlessly integrates with ExcelsiusGPS, enabling intraoperative imaging and robotic navigation to work together within a streamlined procedural workflow. Its compact footprint and omnidirectional wheels facilitate easy positioning and transport within the operating room, while providing surgeons and operating room teams with multiple imaging modalities in one comprehensive platform, according to the company.

“Excelsius3D was developed with a focus on bringing advanced imaging capabilities into a mobile platform that can integrate within the surgical workflow,” Globus Medical Chief Technology Officer Norbert Johnson stated. “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.”

Excelsius3D is designed to function as a stand-alone intraoperative imaging platform or as an integrated component of the Excelsius Ecosystem with ExcelsiusGPS. This flexibility enables hospitals and surgical teams to leverage the system’s advanced imaging capabilities across various intraoperative applications while also supporting an integrated imaging and robotic navigation workflow when used with ExcelsiusGPS.

The Excelsius3D system received U.S. Food and Drug Administration (FDA) 510(k) clearance in 2021. With CE marking, Globus Medical will begin commercializing Excelsius3D in the European Union and United Kingdom.

Globus Medical Inc. is a global musculoskeletal technology company solving unmet clinical needs by providing education and clinical support and advancing care in spine, orthopedic trauma, joint reconstruction, biomaterials, and enabling technologies.