Fusion Robotics Gains FDA Clearance for Spinal Navigation & Robotics

By Julie A. Vetalice

Fusion Robotics Gains FDA Clearance for Spinal Navigation & Robotics

Fusion Robotics was granted FDA 510(k) clearance to market their 3D imaging compatible navigation and robotic targeting system for spine surgery. U.S. launch will occur within the year.

The system addresses key limitations of current spinal navigation and robotics, offering greater procedural efficiency with less expense.

"We appreciate the partnership developed with FDA to rigorously validate safety and accuracy. Next, we look forward to partnering with clinicians and hospitals to increase efficiency, reduce cost and broadly expand the application of robotics to treat patients," said Brad Clayton, CEO of Fusion Robotics.

Product Labels: Surgical Navigation, Robot-Assisted Systems

Tags: 510(k) Clearance, Regulatory