Globus Medical, Inc. has received CE marking for its Excelsius3D intelligent 3-in-1 imaging system, clearing the path for commercial sale in the European Union and the United Kingdom.

What the CE mark covers

Excelsius3D is a mobile X-ray system designed for 2D fluoroscopy, 2D digital radiography, and 3D cone-beam computed tomography in a single platform. Indicated for use in adult and pediatric patients, the system provides 2D and 3D information on anatomic structures and high-contrast objects such as bony anatomy and metallic objects. Its images are compatible with image-guided systems, including the ExcelsiusGPS robotic navigation system.

The system is designed for intraoperative use and features a compact footprint with omnidirectional wheels to facilitate positioning and transport within the operating room. It can function as a stand-alone intraoperative imaging platform or as an integrated component of the broader Excelsius Ecosystem alongside ExcelsiusGPS.

Integration with the Excelsius Ecosystem

The CE marking expands Globus Medical's Excelsius Ecosystem of enabling technologies and enhances the capabilities of the ExcelsiusGPS robotic navigation system in the European Union. The integration connects intraoperative imaging, navigation, and robotics within a single procedural workflow.

Key features of the Excelsius3D system include:

• Combined 3D cone-beam CT, 2D fluoroscopy, and digital radiography in one platform
• Seamless integration with ExcelsiusGPS for intraoperative imaging and robotic navigation
• Compact footprint with omnidirectional wheels for operating room mobility
• Stand-alone or integrated deployment flexibility for hospitals and surgical teams

Regulatory milestones

The following table summarises the regulatory clearances obtained for the Excelsius3D system:

The U.S. Food and Drug Administration granted 510(k) clearance for Excelsius3D in 2021. With CE marking now secured, Globus Medical plans to begin commercialising the system in the European Union and United Kingdom markets.

Executive commentary

Keith Pfeil, President and Chief Executive Officer of Globus Medical, described the CE mark as an important milestone in the continued expansion of the Excelsius Ecosystem, noting the company's commitment to bringing enabling technologies to surgeons globally. Norbert Johnson, Chief Technology Officer, highlighted that the system was developed to bring advanced imaging capabilities into a mobile platform that integrates within the surgical workflow, with its connection to ExcelsiusGPS representing a step toward linking imaging, navigation, and robotics within the ecosystem.

Globus Medical (NYSE: GMED) announced the acquisition of Higgs Boson Health on Aug. 26, 2026. The deal integrates AI-driven digital tools into the company’s musculoskeletal technology ecosystem. Financial terms were not disclosed.

Higgs Boson Health, based in Durham, NC and incubated out of Duke University, will join Globus Medical to shape patient and provider experiences throughout the full episode of care. The acquisition targets the enhancement of real-time information and surgical intelligence available to healthcare providers.

Strategic Integration

David Paul, Founder and Executive Chairman, stated that Higgs Boson’s teams of software developers and AI scientists will power a seamless digital healthcare environment. The goal is to simplify the patient journey while aiming for 95% good outcomes at 10 years for all musculoskeletal surgeries.

Keith Pfeil, President and Chief Executive Officer, described the move as the next step in building the Globus ecosystem. The technology will form part of the surgical intelligence pillar, integrating outcomes and analytics in a closed-loop manner to foster continuous learning along the full patient journey.

What the Numbers Show

The acquisition focuses on non-financial operational metrics rather than immediate revenue contribution. The stated target of achieving 95% good outcomes at 10 years represents a long-term clinical performance benchmark rather than a short-term financial return indicator.