FDA Approves Globus Medical's Consolidated Imaging System

  • The FDA has approved Globus Medical Inc's GMED Excelsius3D, an intelligent intraoperative 3-in-1 imaging system.
  • The imaging platform 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. 
  • The system offers omnidirectional wheels and the elimination of a separate viewing station.
  • Globus Medical is ramping up production and preparing for commercial release in Q4 of 2021.
  • Excelsius3D is a mobile X-ray system designed for 2D fluoroscopy, 2D digital radiography, and 3D imaging of adult and pediatric patients. 
  • Price Action: GMED shares closed 2.04% higher at $77.96 on Monday.
  • Related content: Benzinga's Full FDA Calendar.
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