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MedTech Outlook | Monday, November 07, 2022
Accelus gets FDA 510(k) clearance for the Remi Robotic Navigation System software update, which permits image acquisition with all major 3d imaging systems.
FREMONT, CA: “Cost, footprint, and complexity were previously unscalable barriers that kept robotic spine surgery from being performed anywhere but at large hospitals; however, the Remi systems new clearance provides smaller facilities and ambulatory surgery centers (ASCs) with access to its disruptive technology that can help precisely navigate for accurate screw placement with reduced reliance on traditional fluoroscopy," says Chris Walsh, Acceluss Chief Executive Officer, and Co-Founder. FDA has approved Accelus' Remi Robotic Navigation System software update so that images can be captured using the GE OEC 3D, Ziehm Vision RFD 3D, and Stryker Airo TruCT systems. Accelus is a privately held medical technology company dedicated to promoting the widespread adoption of MIS as the gold standard of spine care.
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“We are proud to have achieved this next step as we look to fulfilling the remaining unmet needs in spinal robotic navigation and are excited to now be able to offer our Remi Robotic Navigation System to so many more facilities and surgeons,” adds Walsh.
Surgeons who need to perform lumbar spine fixation can now benefit from robotic-assisted pedicle screw placement thanks to the Remi Robotic Navigation System, a robotic targeting and navigation platform. The FDA was approved in February 2021 after an O-arm scan was used to determine the patient's anatomical landmarks. With the new FDA approval, the system can be utilized with a broader range of 3D imaging systems, which can help break down some of the traditional limitations of robotic navigation.
The Remi system was created to solve the intrinsic limitations of conventional robotic spine systems, such as lengthy setup and teardown times, high prices, procedural workflow delays, and a huge footprint in the operating room (O.R.). This new approval increases the benefits of the Remi system by allowing it to be utilized with various 3D imaging systems, reducing the requirement for hospitals to purchase a single imaging platform.
“The Remi system addresses the concerns of previous spinal navigation systems with equivalent accuracy and an optimized procedural workflow at a fraction of the cost. The ability to combine it with the GE OEC 3D system is game-changing for my practice,” says Ernest Braxton, MD, MBA, a neurosurgeon at Vail-Summit Orthopaedics and Neurosurgery. “Being able to utilize robotic navigation in an ASC outpatient setting provides me with the precision I need with less radiation exposure for my patients, my O.R. team, and me. It's a win-win-win.”
There will be a software update for all Remi Robotic Navigation Systems in the field, and they will continue to be compatible with O-arm imaging.
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