Boulder, Colo.-based Fusion Robotics, LLC, announces that the U.S. FDA has granted it 510(k) clearance to market its 3D imaging compatible navigation and robotic targeting system for spine surgery in the United States. The Fusion Robotics System addresses the key limitations of current spinal navigation and robotics systems by offering greater procedural efficiency with significantly less expense, company officials say.
“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,” says Brad Clayton, CEO of Fusion Robotics.
Kevin Foley, MD, Fusion Robotics’ chief medical officer, adds: “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.”
The company plans to commercialize broadly across the U.S. in 2021.