Accelus Remi Robotic System Cleared for Use with GE Imaging System

The FDA has granted 510(k) clearance to Accelus’ Remi robotic navigation system for use with GE OEC 9900 C-Arm fluoroscopic imaging systems to help surgeons with robotic-assisted pedicle screw placement procedures in the lumbar spine.

The Remi system includes a near-field optical tracking camera to track spinal instruments relative to an anatomical model based on 2D or 3D images of the patient.

The system previously received FDA’s clearance for use in with the Medtronic O-arm 3D imaging system, as well as the GE OEC 3D, Ziehm Vision RFD 3D, and Stryker Airo TruCT imaging systems.

Initial surgeries with the Remi 2D system are expected to begin in July and a full commercial launch is planned for the late third quarter of this year.