Globus Medical wins CE Mark for Excelsius3D imaging system in EU and UK

Globus Medical has received CE marking for its Excelsius3D imaging system, clearing the device for commercial sale across the European Union and the United Kingdom. The clearance extends the company's Excelsius Ecosystem of surgical enabling technologies into the European market and pairs the imaging platform formally with its ExcelsiusGPS robotic navigation system.

Excelsius3D combines three imaging modalities in a single mobile unit: three-dimensional cone-beam computed tomography, two-dimensional fluoroscopy, and digital radiography. Designed for intraoperative use, the system is built on an omnidirectional wheel chassis to allow repositioning within an operating theatre without disrupting sterile workflow. Globus says the platform can function as a standalone imaging device or as an integrated component of the broader Excelsius Ecosystem when paired with ExcelsiusGPS.

Keith Pfeil, president and chief executive of Globus Medical, said the CE mark "further expands the capabilities of our platform by combining intraoperative imaging with the robotic navigation capabilities of ExcelsiusGPS across the European Union." Chief technology officer Norbert Johnson added that the integration "represents an important step in connecting imaging, navigation, and robotics within the Excelsius Ecosystem."

The system first cleared regulatory review in the United States, receiving FDA 510(k) clearance in 2021. The European approval comes five years later, a gap that reflects the more complex CE marking pathway under the EU Medical Device Regulation, which came into full effect in 2021 and has extended review timelines across the sector.

Market context

Intraoperative imaging integrated with robotic navigation is a contested segment in surgical medtech. Competitors including Stryker, with its O-arm and Mako platforms, and Medtronic, with its O-arm paired to the StealthStation navigation suite, have pursued similar ecosystem strategies in spine and orthopaedic surgery. The competitive logic is consistent: locking hospitals into a proprietary set of complementary technologies raises switching costs and supports recurring revenue from disposables and software subscriptions.

Globus Medical's position in this landscape was materially strengthened by its 2023 merger with NuVasive, which expanded its spine portfolio and sales infrastructure. The combined entity now has the commercial reach to push Excelsius3D into European hospital systems more aggressively than Globus could have managed alone before that transaction closed.

Regulatory and commercial outlook

With CE marking secured, Globus said it will begin commercialising Excelsius3D in EU and UK markets immediately. The company has not disclosed a launch pricing structure or named specific health system customers. For hospital procurement teams, the key near-term questions are whether Excelsius3D will be offered as a bundled package with ExcelsiusGPS or priced independently, and how reimbursement pathways for robot-assisted spine procedures in major European markets will evolve to accommodate the added imaging step.

The broader intraoperative imaging market is growing as surgical teams seek to reduce radiation exposure while maintaining image quality, and as value-based care models reward reduced revision surgery rates. A combined navigation and imaging workflow, if it demonstrably reduces pedicle screw malposition or implant misalignment, carries a credible clinical and health-economic argument to European payers. Globus will need to present that evidence to drive adoption beyond early adopter centres.