Fusion Robotics receives FDA clearance for spinal navigation and robotics system

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Fusion Robotics has announced receiving 510(k) clearance from the US Food and Drug Administration (FDA) to market their 3D imaging-compatible navigation and robotic targeting system for spine surgery in the US market.

Brad Clayton, CEO of Fusion Robotics, Louisville, USA, said: “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.” 

Fusion Robotics Chief Medical Officer, Kevin Foley, Memphis, USA, added that “since the introduction of robotics in spine surgery, the questions of economics and efficiency have hindered the widespread adoption of this technology. With this clearance, and the rapid development of our fluoroscopy-integrated system, we’re working quickly towards making robotics available to many more surgeons, in a form better suited to their practices.”


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