Accelus Announces FDA 510(k) Clearance of Remi Robotic Navigation System

Friday, March 17, 2023

Accelus announced that the U.S. Food & Drug Administration (FDA) has issued a 510(k) clearance to Accelus for its Remi® Robotic Navigation System for use with GE OEC 9900 C-Arm fluoroscopic imaging systems.

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.

The adoption of robotic and navigated technology for spine surgery is challenging with high capital cost of incumbent systems plus the expensive 3D imaging systems required for the use. In addition, previous systems require a large operating room (OR) footprint, steep learning curves, procedural workflow disruptions, and increased setup, teardown and procedural time.

The Remi Robotic Navigation System is designed to eliminate barriers at a fraction of the cost of incumbent systems, now with the ability to utilise 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, and
•    minimised line-of-sight constraints due to its lightweight, nearfield camera.

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