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Accelus was granted FDA 510(k) clearance for its Remi Robotic Navigation System for use with GE OEC 9900 C-Arm fluoroscopic imaging systems.
Remi Robotic Navigation is a robotic targeting and navigation platform that assists surgeons with robotic-assisted pedicle screw placement in the lumbar spine. The Remi 2D system utilizes 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 FDA in 2021 for use with the Medtronic O-arm 3D imaging system, and in 2022 for use with the 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,” said Accelus Chief Executive Officer, Chris Walsh. “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 Robotic Navigation was designed to eliminate barriers of high capital cost, size, steep learning curves, etc. at a fraction of the cost of incumbent systems, now with the ability to utilize it with both 2D and 3D imaging technology.
Other significant improvements include:
- A surgeon-centric, simplified workflow designed to reduce the learning curve and negate the need for an additional resource in the OR to run the system
- A small, portable footprint that allows the system to be used in multiple rooms and for multiple procedures in a given day
- Procedural efficiency with reduced setup and teardown times
- Minimized line-of-sight constraints due to its lightweight, nearfield camera
Initial surgeries with the Remi 2D are expected to begin in July, with a full commercial launch of the system anticipated in late 3Q23.
Source: Accelus
Accelus was granted FDA 510(k) clearance for its Remi Robotic Navigation System for use with GE OEC 9900 C-Arm fluoroscopic imaging systems.
Remi Robotic Navigation is a robotic targeting and navigation platform that assists surgeons with robotic-assisted pedicle screw placement in the lumbar spine. The Remi 2D system utilizes a near-field...
Accelus was granted FDA 510(k) clearance for its Remi Robotic Navigation System for use with GE OEC 9900 C-Arm fluoroscopic imaging systems.
Remi Robotic Navigation is a robotic targeting and navigation platform that assists surgeons with robotic-assisted pedicle screw placement in the lumbar spine. The Remi 2D system utilizes 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 FDA in 2021 for use with the Medtronic O-arm 3D imaging system, and in 2022 for use with the 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,” said Accelus Chief Executive Officer, Chris Walsh. “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 Robotic Navigation was designed to eliminate barriers of high capital cost, size, steep learning curves, etc. at a fraction of the cost of incumbent systems, now with the ability to utilize it with both 2D and 3D imaging technology.
Other significant improvements include:
- A surgeon-centric, simplified workflow designed to reduce the learning curve and negate the need for an additional resource in the OR to run the system
- A small, portable footprint that allows the system to be used in multiple rooms and for multiple procedures in a given day
- Procedural efficiency with reduced setup and teardown times
- Minimized line-of-sight constraints due to its lightweight, nearfield camera
Initial surgeries with the Remi 2D are expected to begin in July, with a full commercial launch of the system anticipated in late 3Q23.
Source: Accelus
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
