Globus Medical reported a regulatory milestone when its Excelsius3D imaging system secured CE mark approval for commercial sale across the European Union and the United Kingdom. The company said it will begin commercializing the system in those regions, a step that coincided with roughly a 1% rise in Globus Medical, Inc. (NYSE:GMED) shares in after-hours trading on Thursday.
Excelsius3D is a mobile imaging platform that merges three imaging modalities into a single system: 3D cone-beam computed tomography, 2D fluoroscopy, and digital radiography. The product is designed to support intraoperative imaging and, when paired with Globus Medical's ExcelsiusGPS robotic navigation system, to enable robotic navigation within surgical workflows.
The device previously received U.S. Food and Drug Administration 510(k) clearance in 2021. With the newly obtained CE marking, the company stated it will initiate commercial distribution of Excelsius3D in EU and UK markets.
Commenting on the approval, Keith Pfeil, President and Chief Executive Officer of Globus Medical, said: "The CE mark for Excelsius3D represents an important milestone in the continued expansion of the Excelsius Ecosystem."
According to the company's description, the system can operate as a stand-alone intraoperative imaging platform or as an integrated component paired with ExcelsiusGPS. Excelsius3D is indicated for clinical use where physicians require both 2D and 3D views of anatomic structures and high contrast objects that exhibit high X-ray attenuation - such as bony anatomy and metallic objects - in both adult and pediatric patients.
The announcement centers on regulatory approval and the start of commercialization in specific international markets. Beyond the CE mark and the prior U.S. clearance, the company did not provide additional operational or commercial detail in connection with this release.
Market reaction was modest in after-hours trading, reflecting the announcement's targeted scope: regulatory clearance for a single product and the commencement of sales activity in defined geographies.