Fusion Robotics receives FDA clearance for spinal navigation, robotics system
Fusion Robotics LLC has announced FDA 510(k) clearance for the Fusion Robotics System for use in spine surgery in the United States, according to a press release.
The 3D imaging compatible navigation and robotic targeting system allows for greater procedural efficiency at a lower cost, according to the release.
“We appreciate the partnership developed with FDA to rigorously validate safety and accuracy,” Brad Clayton, CEO of Fusion Robotics, said in the release. “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,” Clayton added.
Kevin Foley, MD, chief medical officer of Fusion Robotics, said in the release. “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,” Foley said.