FDA clearance addresses 'cost, footprint and complexity' with Accelus spine robot


Accelus earned FDA 510(k) clearance for software that will let its Remi spine robot integrate with three 3D imaging systems.

The Remi robotic navigation system will be able to capture images with the GE OEC 3D, Ziehm Vision RFD 3D and Stryker Airo TruCT systems, according to a Nov. 3 Accelus news release. 

"Cost, footprint and complexity were previously unscalable barriers that kept robotic spine surgery from being performed anywhere but at large hospitals; however, the Remi system's new clearance provides smaller facilities and ambulatory surgery centers with access to its disruptive technology that can help precisely navigate for accurate screw placement with reduced reliance on traditional fluoroscopy," Accelus CEO Chris Walsh said in the release.

Remi is used to assist surgeons with pedicle screw placement for lumbar spine fixations. It earned FDA clearance in February 2021 with imaging done through an O-arm scan.

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