Globus Medical Announces FDA 510(k) Clearance for Excelsius3D

By Julie A. Vetalice

Globus Medical Announces FDA 510(k) Clearance for Excelsius3D

Globus Medical received FDA 510(k) clearance to market Excelsius3D™, an intelligent intraoperative 3-in-1 imaging system. The company is ramping up production and preparing for commercial release in 4Q21.

Excelsius3D is a 3-in-1 platform that consolidates 360° cone-beam CT, fluoroscopy and high-resolution digital radiography into one solution, eliminating the need for multiple imaging systems during one procedure. Precise motion, omnidirectional wheels and intelligent maneuverability offer unmatched 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 present Excelsius™ ecosystem.

Excelsius3D is a mobile X-ray system designed for 2D fluoroscopy, 2D digital radiography and 3D imaging of adult and pediatric patients. The system is indicated for use where a physician benefits from 2D and 3D information on anatomic structures and high contrast objects with high x-ray attenuation such as bony anatomy and metallic objects. Excelsius3D images are compatible with image guided systems such as ExcelsiusGPS®.

“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,” commented Kelly Baker, PhD, Senior Vice President, 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.”

Source: Globus Medical

Product Labels: Surgical Planning

Tags: 510(k) Clearance, Regulatory