Globus Medical recently announced that it has received FDA 510(k) clearance for its Excelsius3D intelligent intraoperative 3-in-1 imaging system.
Audubon, Pa.–based Globus Medical designed the image platform with 360º cone-beam CT, fluoroscopy and high-resolution digital radiography to eliminate the need for multiple imaging systems in one procedure.
“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,” Kelly Baker, senior VP of regulatory and clinical affairs, said in a news release. “We are excited to expand into a new product space with the FDA and help bring this truly innovative system to market.”
The imaging system is a mobile X-ray system that is designed for 2D fluoroscopy, 2D digital radiography and 3D imaging of adult and pediatric patients.
Excelsius3D features precise motion, omnidirectional wheels and intelligent maneuverability, according to Globus Medical. It has a compact footprint and eliminates a separate viewing station.
Globus Medical said it is ramping up production of the imaging system and will commercially launch in the fourth quarter.