The FDA has awarded Globus Medical 510(k) clearance for Excelsius3D, an intraoperative three-in-one imaging system.
Excelsius3D consolidates 360-degree cone-beam CT, fluoroscopy and high-resolution digital radiography into one platform to eliminate the need for multiple imaging systems for one procedure.
"The compact footprint and elimination of a separate viewing station amplify the system's agility and efficiency," Globus Medical said in an Aug. 16 news release.
The company said it is ramping up production and preparing for a fourth-quarter commercial launch.