Audubon, Pa.-based Globus Medical, Inc. announces that the U.S. FDA has granted 510(k) clearance to the Excelsius3D intraoperative three-in-one imaging system. Excelsius3D consolidates 360-degree cone-beam CT, fluoroscopy, and high-resolution digital radiography into one unified solution, eliminating the need for multiple imaging systems during one procedure.
Precise motion, omnidirectional wheels, and strong maneuverability offer advanced imaging capability. The compact footprint and elimination of a separate viewing station amplify the system’s agility and efficiency. Excelsius3D functions as a standalone imaging unit or as an extension to the Excelsius ecosystem.
“Excelsius3D underwent rigorous performance testing of various capabilities to support this 510(k) clearance, as it is our first imaging system 510(k) to be filed with the FDA’s Office of In Vitro Diagnostics and Radiological Health,” says Kelly Baker, PhD, senior vice rresident, regulatory and clinical affairs. “We are excited to expand into a new product space with the FDA and help bring this truly innovative system to market.”
With 510(k) FDA clearance in hand, Globus Medical is ramping up production and preparing for commercial release in the fourth quarter.