Fusion Robotics this week announced that it has received FDA 510(k) clearance for its robotics system.
The Fusion Robotics System is a 3D imaging compatible navigation and robotic targeting system for spinal surgery.
“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,” CEO Brad Clayton said in a news release.
“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,” chief medical officer Kevin Foley said.
Fusion Robots plans to commercialize broadly across the U.S. in 2021.