Accelus announced that it received FDA 510(k) clearance for its Remi robotic navigation system for use with GE OEC 9900 C-Arm fluoroscopic imaging systems.
Palm Beach Gardens, Florida-based Accelus designed Remi for robotic targeting and navigation. It assists surgeons with robotic-assisted pedicle screw placement in the lumbar spine. The system utilizes a near-field optical tracking camera to track spinal instruments relative to an anatomical model. This tracking is based on 3D imaging or 2D fluoroscopic images of the patient.
Remi previously received FDA clearance in February 2021 for use with the Medtronic O-arm 3D imaging system. In October 2022, it picked up clearance for use with the GE OEC 3D, Ziehm Vision RFD 3D and Stryker Airo TruCT.
“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 CEO 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.”
More about the Accelus Remi robot
Accelus says high capital costs of incumbent systems and expensive 3D imaging systems prove challenging for surgical robotic adoption. Previous systems also have large OR footprints, steep learning curves, workflow disruptions and more, the company said.
It designed Remi to eliminate these barriers “at a fraction of the cost of incumbent systems.” Now, it has the ability to work with both 2D and 3D imaging technology.
Accelus said other improvements include a surgeon-centric, simplified workflow and a small, portable footprint. The system can run in multiple rooms for multiple procedures in a given day. Additionally, it features procedural efficiency with reduced setup and teardown times, plus minimized line-of-sight constraints with a lightweight, nearfield camera.
The company expects to begin initial Remi 2D surgeries in July. Accelus then plans for a full commercial launch late in the third quarter of 2023.