Accelus has announced that the US Food & Drug Administration (FDA) has issued it 510(k) clearance for its Remi robotic navigation system for use with OEC 9900 c-Arm fluoroscopic imaging systems (GE Healthcare).
The Remi robotic navigation system is a robotic targeting and navigation platform that assists surgeons with robotic-assisted pedicle screw placement in the lumbar spine. The Remi 2D system utilises a near-field optical tracking camera to track spinal instruments relative to an anatomical model based on a 3D imaging scan or 2D fluoroscopic images of the patient.
Remi was previously cleared by the FDA in February 2021 for use with the Medtronic O-arm 3D imaging system, and in October 2022 for use with the GE OEC 3D, Ziehm Vision RFD 3D, and Stryker Airo TruCT imaging systems.
Chris Walsh, Accelus’ chief executive officer, said: “Most hospitals and ambulatory surgery centres (ASCs) are already utilising C-arm X-ray fluoroscopy in their surgeries, which means they do not need additional imaging technology to utilise the Remi robotic navigation system, thanks to Remi’s most current FDA clearance.
“This allows Remi to be used in smaller hospitals and ASCs and for Accelus to continue to meet the needs of spine surgeons in ways that our competitors have not been able to do.”
Kevin Foley, chairman of the Semmes Murphey Neurologic & Spine Institute and chief robotics officer of Accelus, added: “Remi was developed with the knowledge that robotic navigation systems need to be practical, reproducible and cost-effective in order to appeal to a broad range of spine surgeons and facilities.
“Remi not only provides equivalent accuracy to legacy spinal robotic systems, but it also addresses the significant limitations associated with those systems, even more so now that it is cleared for use with 2D imaging.”
Initial surgeries with the Remi 2D are expected to begin in July with a full commercial launch of the system anticipated in late Q3 2023.