Globus Medical has secured the CE mark for its Excelsius3D imaging system, clearing the way for commercial sales of the platform in the EU and the UK.
The company stated that Excelsius3D will broaden the capabilities of its Excelsius Ecosystem by enhancing its ExcelsiusGPS robotic navigation system in Europe.
The Excelsius3D system is a mobile imaging platform designed to combine three imaging modalities, 3D cone-beam computed tomography (CT), 2D fluoroscopy, and digital radiography, within a single device.
The system is built for intraoperative use and can be utilised either on its own or integrated with the ExcelsiusGPS robotic navigation system.
Globus Medical said the integration enables imaging and robotic navigation to be performed together during procedures.
Excelsius3D is designed with a compact footprint and multidirectional wheels, which the company says are intended to make it easier to position and move within operating theatres.
The platform aims to offer multiple imaging options to surgeons and surgical teams during operations.
Globus Medical president and CEO Keith Pfeil said: "The CE mark for Excelsius3D represents an important milestone in the continued expansion of the Excelsius Ecosystem.
"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."
Excelsius3D first obtained clearance from the US Food and Drug Administration through the 510(k) process in 2021.
With the new CE marking, Globus Medical plans to commence commercialisation efforts in the EU and UK markets.
Excelsius3D is indicated as a mobile X-ray system intended for use in 2D fluoroscopy, 2D digital radiography, and 3D imaging for both adult and paediatric patients.
The company noted that these images are compatible with image-guided systems such as ExcelsiusGPS.
In February 2025, Globus Medical agreed to acquire spinal cord stimulation company Nevro for $250m to reinforce its position in the neuromodulation sector. The deal was completed in April 2025.
"Globus Medical's Excelsius3D imaging system receives CE mark" was originally created and published by Medical Device Network, a GlobalData owned brand.