AUDUBON, PA — Globus Medical Inc. (NYSE: GMED) secured CE marking for its Excelsius3D surgical imaging system, clearing the company to begin selling the platform in the European Union and United Kingdom and expanding the overseas reach of its robotic-navigation technology.
Excelsius3D combines 3D cone-beam computed tomography, 2D fluoroscopy and digital radiography in a mobile system designed for use during surgery, according to the company.
The system can operate independently or integrate with Globus Medical’s ExcelsiusGPS robotic-navigation platform, connecting intraoperative imaging with navigation and robotics within the same surgical workflow.
The clearance expands the company’s Excelsius product ecosystem in Europe, where hospitals and surgical teams can now deploy Excelsius3D as a stand-alone imaging platform or alongside ExcelsiusGPS.
“The CE mark for Excelsius3D represents an important milestone in the continued expansion of the Excelsius Ecosystem,” Chief Executive Officer Keith Pfeil stated.
Chief Technology Officer Norbert Johnson said integration with ExcelsiusGPS represents “an important step in connecting imaging, navigation, and robotics” within the company’s platform.
Excelsius3D has a compact footprint and omnidirectional wheels intended to facilitate positioning and movement within operating rooms, while consolidating three imaging modalities into one system.
The U.S. Food and Drug Administration granted Excelsius3D 510(k) clearance in 2021. The new CE marking allows Globus Medical to begin commercializing the system in the EU and UK.
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