Fusion Robotics receives FDA 510(k) clearance for spinal navigation & robotics system

Friday February 26, 2021 0 comments Tags: Boulder, Fusion Robotics, Brad Clayton, Kevin Foley, FDA

BOULDER -- Fusion Robotics LLC, a spinal robotics and navigation company, announced receiving 510(k) clearance to market the company’s 3D imaging compatible navigation and robotic targeting system for spine surgery in the U.S. market.fusion-robotics-logo 

The Fusion Robotics System addresses the key limitations of current spinal navigation and robotics systems by offering greater procedural efficiency with significantly less expense, Fusion said.

"We appreciate the partnership developed with FDA to rigorously validate safety and accuracy,” said Brad Clayton, Fusion Robotics CEO.

“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."

"Since the introduction of robotics in spine surgery, the questions of economics and efficiency have hindered the widespread adoption of this technology,” said Fusion Robotics chief medical officer Kevin Foley.

“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 said it plans to commercialize the system broadly across the U.S. in 2021.