Audubon, Pennsylvania, USA, September 3, 2026
Globus Medical has announced that its Excelsius3D™ Imaging System has received the CE Mark, enabling the advanced intraoperative imaging platform to be marketed in applicable European markets. The regulatory milestone expands access to Globus Medical’s imaging technology, which is designed to support spinal and orthopedic surgical procedures by providing three-dimensional imaging during surgery. Integrated with the company’s ExcelsiusGPS® robotic navigation platform, the system is intended to help surgeons obtain detailed anatomical information and support image-guided surgical workflows. The CE Mark represents an important step in Globus Medical’s international expansion of its technology portfolio and highlights the continuing evolution of intraoperative imaging, navigation and robotic-assisted surgery.
Globus Medical Expands 3D Intraoperative Imaging
The Excelsius3D Imaging System is designed to provide high-quality three-dimensional images during surgical procedures, helping clinicians visualize anatomy and assess implant positioning without relying exclusively on conventional two-dimensional imaging. The system is intended for use with the ExcelsiusGPS robotic navigation platform, creating an integrated workflow in which intraoperative imaging can be used to support surgical planning, navigation and verification. Such capabilities are particularly relevant in spine surgery, where accurate understanding of complex anatomy and precise placement of implants are critical components of many procedures. A key feature of the Excelsius3D platform is its ability to generate three-dimensional imaging within the operating environment, allowing surgical teams to obtain updated anatomical information during a procedure. Intraoperative imaging can help clinicians confirm surgical objectives and make adjustments when necessary, potentially reducing reliance on preoperative assumptions. By combining imaging with navigation and robotics, Globus Medical is positioning the system as part of a broader digital surgical ecosystem designed to support precision and workflow efficiency. The technology also reflects a wider trend toward integrating multiple surgical technologies into a single operating-room environment. Robotic assistance, navigation, intraoperative imaging and data-driven surgical planning are increasingly being combined to provide surgeons with more information throughout complex procedures.
CE Mark Opens European Market Opportunities
The CE Mark is an important regulatory milestone for medical-device manufacturers seeking to commercialize products in applicable European markets. For Globus Medical, the authorization provides a pathway to expand availability of Excelsius3D Imaging to healthcare providers and surgical centers across Europe, subject to the relevant market requirements. The milestone is particularly significant for the company’s broader strategy of developing connected technologies for musculoskeletal and orthopedic care. Globus Medical has built its portfolio around technologies intended to support surgeons across different stages of procedures, including implants, navigation, robotics and imaging. The addition of CE-marked Excelsius3D capabilities strengthens the company’s ability to offer an integrated technology platform for image-guided surgery. For hospitals, integrated imaging and navigation systems can potentially streamline surgical workflows by allowing imaging information to be incorporated directly into navigation processes. This may be particularly valuable in procedures where implant alignment and positioning require high levels of precision.
Advertisement
Imaging Technology Supports Robotic Surgical Workflows
The Excelsius3D milestone also highlights the growing role of advanced intraoperative imaging in robotic-assisted surgery. As robotic platforms become more widely adopted, the quality and availability of real-time anatomical information become increasingly important. Three-dimensional imaging can provide surgical teams with detailed views that complement navigation data and help support decision-making during procedures. When combined with the ExcelsiusGPS platform, Excelsius3D is designed to create a connected workflow in which imaging, navigation and robotic assistance work together. This integration reflects the broader movement toward technology-enabled surgery, where medical devices increasingly communicate and operate as components of a unified clinical system rather than as isolated tools. The CE Mark does not itself establish that the system improves clinical outcomes compared with other imaging technologies, and hospitals will continue to evaluate devices based on factors including clinical utility, workflow integration, safety, training requirements and cost. Nevertheless, regulatory clearance represents an important commercial milestone for Globus Medical and provides the foundation for broader European adoption. With the Excelsius3D Imaging System now carrying the CE Mark, Globus Medical has strengthened its international portfolio of technologies supporting robotic, navigated and image-guided orthopedic surgery. The development underscores how advances in three-dimensional imaging and surgical robotics are continuing to reshape modern operating-room workflows while creating new opportunities for more integrated approaches to complex musculoskeletal procedures.
Source: Globus Medical press release
