Globus gets FDA clearance for Excelsius3D

By staff writers

August 17, 2021 -- Medical device firm Globus Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Excelsius3D, an intraoperative imaging platform that can perform conebeam CT, fluoroscopy, and digital radiography on adult and pediatric patients.

Excelsius3D is designed for use in applications where physicians would benefit from 2D and 3D information on anatomic structures and high-contrast objects with high x-ray attenuation, such as bony anatomy and metallic objects, according to the vendor.

It can function on its own, or as an extension to the company's Excelsius ecosystem; Excelsius3D images are compatible with image-guided systems such as its ExcelsiusGPS offering, Globus said. The mobile x-ray system is expected to be released in the fourth quarter.

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