Globus Medical Announces CE Mark for Excelsius3D™
Globus Medical, Inc. has announced that the Excelsius3D™ intelligent 3-in-1 imaging system is now CE marked 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 further enhances the capabilities of the ExcelsiusGPS™ robotic navigation system in the European Union.
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, Excelsius3D™ seamlessly integrates with ExcelsiusGPS™, enabling intraoperative imaging and robotic navigation to work together within a streamlined procedural workflow. Its compact footprint and omnidirectional wheels facilitate easy positioning and transport within the operating room, while providing surgeons and operating room teams with multiple imaging modalities in one comprehensive platform.
“The CE mark for Excelsius3D™ represents an important milestone in the continued expansion of the Excelsius™ Ecosystem,” said Keith Pfeil, President and Chief Executive Officer of Globus Medical. “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™ was developed with a focus on bringing advanced imaging capabilities into a mobile platform that can integrate within the surgical workflow,” said Norbert Johnson, Chief Technology Officer of Globus Medical. “Its integration with ExcelsiusGPS™ represents an important step in connecting imaging, navigation, and robotics within the Excelsius™ Ecosystem, providing surgeons with complementary technologies designed to work together throughout the surgical workflow.”
Excelsius3D™ is designed to function as a stand-alone intraoperative imaging platform or as an integrated component of the Excelsius™ Ecosystem with ExcelsiusGPS™. This flexibility allows hospitals and surgical teams to leverage the system’s advanced imaging capabilities across a range of intraoperative applications while also supporting an integrated imaging and robotic navigation workflow when used with ExcelsiusGPS™.
The Excelsius3D™ system received U.S. Food and Drug Administration (FDA) 510(k) clearance in 2021. With CE marking, Globus Medical will begin commercializing Excelsius3D™ in the European Union and United Kingdom markets.
Source: Globus Medical, Inc.