Globus Medical said on Monday its Excelsius3D imaging system received CE mark certification, allowing commercialization in the European Union and the United Kingdom. The mobile platform integrates 3D cone-beam CT, 2D fluoroscopy, and digital radiography for intraoperative use, designed to enhance surgical navigation and imaging precision.
The system is indicated for 2D and 3D imaging of adult and pediatric patients, particularly for high-contrast anatomical structures such as bones and metallic implants. Its compact design and omnidirectional wheels enable positioning and transport within operating rooms, and it can function independently or integrate with Globus Medical’s ExcelsiusGPS robotic navigation system.
The Excelsius3D received 510(k) clearance from the U.S. Food and Drug Administration in 2021, marking an earlier milestone for the company’s enabling technologies portfolio. Keith Pfeil, Globus Medical’s President and CEO, described the CE mark as a significant step in expanding the Excelsius ecosystem.
Globus Medical, headquartered in Audubon, Pennsylvania, develops musculoskeletal technologies spanning spine, orthopedic trauma, joint reconstruction, biomaterials, and enabling technologies.
