Accelus’s 510(k) Clearance for Robotic System Adds 3D Images

The FDA has granted 510(k) clearance to Accelus’s Remi robotic navigation system software update, which allows for the use of three additional imaging systems — GE OEC 3D, Ziehm Vision RFD 3D and Stryker Airo TruCT.

First cleared by the FDA in February 2021, the Remi system is a navigation platform that provides robotic-assisted pedicle screw placement for lumbar spine fixation.

The new FDA clearance allows the system to be used with a broader portfolio of 3D imaging systems, so hospitals do not have to use a specific imaging platform.

All Remi robotic navigation systems in the field will be updated to the newly cleared software, the company said.