Benzinga | Aug 16, 2021 04:33PM EDT

Globus Medical Reports FDA 510(k) Clearance For Excelsius3D

Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced that Excelsius3D(tm), an intelligent intraoperative 3-in-1 imaging system, has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA).

Excelsius3D(tm) is a 3-in-1 imaging platform that consolidates 360o 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 intelligent maneuverability offer unmatched imaging capability. The compact footprint and elimination of a separate viewing station amplify the system's agility and efficiency. Excelsius3D(tm) functions as an elite, standalone imaging unit, or as an elegant extension to the Excelsius(tm) ecosystem.

"Excelsius3D(tm) 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."

With 510(k) FDA clearance in hand, Globus Medical is ramping up production and preparing for commercial release in the fourth quarter.

Indications for Use

Excelsius3D(tm) 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(tm) images are compatible with image guided systems such as ExcelsiusGPS(r).