Sam Brusco, Associate Editor03.17.23
Accelus has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its Remi robotic navigation system with the GE OEC 9900 C-Arm fluoroscopic imaging systems.
The Remi surgical robot is a robotic targeting and navigation platform to help surgeons perform robotic-assisted pedicle screw placement in the lumbar spine. The Remi 2D system uses a near-field optical tracking camera to track spinal instruments relative to an anatomical model based on 3D imaging scan or 2D fluoroscopic patient images.
Remi was previously FDA cleared in February 2021 with the Medtronic O-arm 3D imaging system, and in October 2022 for use with GE OEC 3D, Ziehm Vision RFD 3D, and Stryker Airo TruCT imaging systems.
“Most hospitals and ambulatory surgery centers (ASCs) are already utilizing C-arm X-ray fluoroscopy in their surgeries, which means they do not need additional imaging technology to utilize the Remi Robotic Navigation System, thanks to Remi’s most current FDA clearance,” Accelus CEO Chris Walsh told the press. “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.”
Remi includes a surgeon-centric, simplified workflow to reduce learning curve and remove need for further OR resources to run the system. It has a small, portable footprint so the system can be used in multiple room and multiple procedures in a given day. Reduce setup and teardown times boost procedural efficiency, and a lightweight, nearfield camera minimizes line-of-sight constraints.
“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,” said Dr. Kevin Foley, Chairman of the Semmes Murphey Neurologic & Spine Institute and chief robotics officer of Accelus. “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.”
Remi 2D’s initial surgeries are planned to begin in July, with full commercial launch expected in late Q3 2023.
The Remi surgical robot is a robotic targeting and navigation platform to help surgeons perform robotic-assisted pedicle screw placement in the lumbar spine. The Remi 2D system uses a near-field optical tracking camera to track spinal instruments relative to an anatomical model based on 3D imaging scan or 2D fluoroscopic patient images.
Remi was previously FDA cleared in February 2021 with the Medtronic O-arm 3D imaging system, and in October 2022 for use with GE OEC 3D, Ziehm Vision RFD 3D, and Stryker Airo TruCT imaging systems.
“Most hospitals and ambulatory surgery centers (ASCs) are already utilizing C-arm X-ray fluoroscopy in their surgeries, which means they do not need additional imaging technology to utilize the Remi Robotic Navigation System, thanks to Remi’s most current FDA clearance,” Accelus CEO Chris Walsh told the press. “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.”
Remi includes a surgeon-centric, simplified workflow to reduce learning curve and remove need for further OR resources to run the system. It has a small, portable footprint so the system can be used in multiple room and multiple procedures in a given day. Reduce setup and teardown times boost procedural efficiency, and a lightweight, nearfield camera minimizes line-of-sight constraints.
“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,” said Dr. Kevin Foley, Chairman of the Semmes Murphey Neurologic & Spine Institute and chief robotics officer of Accelus. “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.”
Remi 2D’s initial surgeries are planned to begin in July, with full commercial launch expected in late Q3 2023.
