Globus Medical, the Montgomery County musculoskeletal technology company, announced on September 3 that its Excelsius3D imaging system has received CE marking, clearing the way for the company to start selling the device across the European Union and the United Kingdom.
“The CE mark for Excelsius3D™ represents an important milestone in the continued expansion of the Excelsius™ Ecosystem,” said Keith Pfeil, President and Chief Executive Officer of Globus Medical. “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.”
What Excelsius3D Actually Does
Excelsius3D™ packs 3D cone-beam CT, 2D fluoroscopy, and digital radiography into one mobile platform built for use during surgery. It’s meant to work hand-in-hand with ExcelsiusGPS, letting imaging and robotic navigation happen within the same procedural workflow rather than as separate steps. The system’s small footprint and omnidirectional wheels make it easy to reposition and move around the OR, giving surgical teams several imaging modes in a single machine.
Excelsius3D™ was developed with a focus on bringing advanced imaging capabilities into a mobile platform that can integrate within the surgical workflow,” said Norbert Johnson, Chief Technology Officer of Globus Medical. “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.”
Hospitals can run Excelsius3D on its own or as part of the broader Excelsius Ecosystem alongside ExcelsiusGPS, giving surgical teams the option to use it for general intraoperative imaging or as a component of a fully integrated navigation setup. The system picked up FDA 510(k) clearance in 2021, and the new CE mark now lets Globus start selling it commercially across the EU and UK.
Not an Isolated Announcement in Globus’s Year
This CE mark lands in the middle of a busy stretch for the company. Globus also announced the acquisition of digital health company Higgs Boson Health in late August and reported second-quarter earnings in early August, and it closed its $250 million acquisition of spinal cord stimulation company Nevro in April 2025 to expand into neuromodulation. The Excelsius3D CE mark is a regulatory milestone rather than a corporate transaction, and it stands on its own as news, but it’s worth reading as one more piece of a company that has spent the past two years adding capabilities through both M&A and internal product development.
Indications for Use: Excelsius3D™
Excelsius3D™ is a mobile X-ray system designed for 2D fluoroscopy, 2D digital radiography, and 3D imaging of adult and pediatric patients. The system is indicated for use where a physician benefits from 2D and 3D information on anatomic structures and high contrast objects with high X-ray attenuation such as bony anatomy and metallic objects. Excelsius3D™ images are compatible with image guided systems such as ExcelsiusGPS™.
About Globus Medical, Inc.
Globus Medical is a publicly traded musculoskeletal technology company headquartered in Audubon, Pennsylvania, founded in 2003 by David Paul. The company designs and manufactures implants and surgical technologies across spine, orthopedic trauma, and joint reconstruction, and has expanded significantly since its 2023 merger with NuVasive. Beyond its device portfolio, Globus has built out an “enabling technologies” business that includes the ExcelsiusGPS robotic navigation platform and now Excelsius3D. The company describes its mission as closing gaps in patient care through engineering and surgeon education, and it’s grown into one of the larger players in the global spine and orthopedics market.
