Accelus’ Remi gets FDA nod
US-based Accelus has secured a 510(k) clearance from the US Food and Drug Administration (FDA) for its Remi Robotic Navigation System to be used with GE OEC 9900 C-Arm fluoroscopic imaging systems.
The Remi Robotic Navigation System is a robotic targeting and navigation platform that is intended to support surgeons with robotic-assisted pedicle screw placement in the lumbar spine.
The medical technology company said that the Remi 2D system uses a near-field optical tracking camera for tracking spinal instruments. The tracking is in relation to an anatomical model based on a 3D imaging scan or 2D fluoroscopic images of the patient.
The Remi Robotic Navigation System has already received FDA clearance for use with the Medtronic O-arm 3D imaging system in February 2021. It was also cleared by the regulator in October 2022 for use with the GE OEC 3D, Ziehm Vision RFD 3D, and Stryker Airo TruCT imaging systems.
Accelus CEO Chris Walsh said: “Most hospitals and ambulatory surgery centres (ASCs) are already utilizing 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.”
According to Accelus, the Remi robotic system is surgeon-centric with a simplified workflow to reduce the learning curve and eliminate the need for an additional resource in the operating room to run the system.
Its small, portable footprint enables the system to be used in multiple rooms and for multiple procedures on a given day, the medical technology firm claimed.
Accelus said that the Remi System has improved procedural efficiency with reduced setup and teardown times.
Additionally, the robotic and navigation system has reduced the line-of-sight constraints due to the presence of a lightweight, near-field camera, said the company. NS Medical Devices