Mobile 3-in-1 Imaging System Advances Intraoperative Navigation

Globus Medical’s Excelsius3D intelligent 3-in-1 imaging system has received the CE Mark for commercial sale in the European Union and the United Kingdom. The addition of Excelsius3D expands the company’s Excelsius Ecosystem of enabling technologies and enhances the capabilities of the ExcelsiusGPS robotic navigation system in Europe. The system is intended to support a connected platform for intraoperative imaging and guidance.

Excelsius3D is an intelligent, mobile imaging platform that combines 3D cone‑beam computed tomography (CT), 2D fluoroscopy, and digital radiography in a single system. Designed for intraoperative use, it integrates with ExcelsiusGPS so intraoperative imaging and robotic navigation work together within a streamlined procedural workflow. A compact footprint and omnidirectional wheels facilitate positioning and transport in the operating room while offering multiple imaging modalities in one platform.

Indications for use specify that Excelsius3D is a mobile X‑ray system designed for 2D fluoroscopy, 2D digital radiography, and 3D imaging of adult and pediatric patients. It is intended for situations in which physicians benefit from 2D and 3D information on anatomic structures and on high‑contrast, high‑attenuation objects such as bony anatomy and metallic objects. Acquired images are compatible with image‑guided systems such as ExcelsiusGPS.

With CE marking, commercialization of Excelsius3D will begin in the European Union and United Kingdom. The system previously received U.S. Food and Drug Administration (FDA) 510(k) clearance in 2021. As part of the Excelsius Ecosystem, it can function as a stand‑alone intraoperative imaging platform or as an integrated component working with ExcelsiusGPS.

“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,” said Keith Pfeil, President and Chief Executive Officer of Globus Medical.

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