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Accelus Announces FDA 510(k) Clearance of Remi Robotic Navigation System for Use with 2D Fluoroscopy-Based Imaging System

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March 17, 2023
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Accelus Announces FDA 510(k) Clearance of Remi Robotic Navigation System for Use with 2D Fluoroscopy-Based Imaging System

Remi now cleared to be used with mostly used 2D and 3D imaging programs for spine surgical procedure.

PALM BEACH GARDENS, Fla., March 16, 2023 (GLOBE NEWSWIRE) — Accelus, a privately held medical know-how firm targeted on accelerating the adoption of minimally invasive surgical procedure (MIS) as the usual of care in spine, right now introduced that the U.S. Food & Drug Administration (FDA) has issued a 510(ok) clearance to Accelus for its Remi® Robotic Navigation System to be used with GE OEC 9900 C-Arm fluoroscopic imaging programs.

The Remi Robotic Navigation System is a robotic concentrating on and navigation platform that assists surgeons with robotic-assisted pedicle screw placement within the lumbar spine. The Remi 2D system makes use of a near-field optical monitoring digital camera to trace spinal devices relative to an anatomical mannequin primarily based on a 3D imaging scan or 2D fluoroscopic pictures of the affected person. Remi was beforehand cleared by the FDA in February 2021 to be used with the Medtronic O-arm 3D imaging system, and in October 2022 to be used with the GE OEC 3D, Ziehm Imaginative and prescient RFD 3D, and Stryker Airo TruCT imaging programs.

“Most hospitals and ambulatory surgical procedure facilities (ASCs) are already using C-arm X-ray fluoroscopy of their surgical procedures, which implies they don’t want extra imaging know-how to make the most of the Remi Robotic Navigation System, due to Remi’s most present FDA clearance,” stated Accelus Chief Government Officer, Chris Walsh. “This permits Remi for use in smaller hospitals and ASCs and for Accelus to proceed to fulfill the wants of spine surgeons in ways in which our opponents haven’t been in a position to do.”

The adoption of robotic and navigated know-how for spine surgical procedure has been considerably challenged by the excessive capital value of incumbent programs plus the costly 3D imaging programs which can be required for his or her use. As well as, earlier programs require a big working room (OR) footprint, steep studying curves, procedural workflow disruptions, and elevated setup, teardown and procedural time.

The Remi Robotic Navigation System was designed to get rid of these obstacles at a fraction of the price of incumbent programs, now with the flexibility to put it to use with each 2D and 3D imaging know-how. Different important enhancements embody:

  • a surgeon-centric, simplified workflow designed to cut back the educational curve and negate the necessity for an extra useful resource within the OR to run the system,
  • a small, transportable footprint that permits the system for use in a number of rooms and for a number of procedures in a given day,
  • procedural effectivity with decreased setup and teardown instances, and
  • minimized line-of-sight constraints on account of its light-weight, nearfield digital camera.

“Remi was developed with the information that robotic navigation programs must be sensible, reproducible and cost-effective to be able to attraction to a broad vary of spine surgeons and services,” stated Dr. Kevin Foley, Chairman of the Semmes Murphey Neurologic & Backbone Institute and Chief Robotics Officer of Accelus. “Remi not solely supplies equal accuracy to legacy spinal robotic programs, but it surely additionally addresses the numerous limitations related to these programs, much more so now that it’s cleared to be used with 2D imaging.”

Preliminary surgical procedures with the Remi 2D are anticipated to start in July with a full industrial launch of the system anticipated in late Q3 2023.

About Accelus
Accelus is dedicated to accelerating minimally invasive spine surgical procedure by means of its enabling know-how with broad accessibility to beforehand underserved markets. Established in 2021 by means of the mixture of Integrity Implants and Fusion Robotics, the corporate is concentrated on offering its proprietary Adaptive Geometry™ know-how with pragmatic and economical navigation and robotic options with broad medical use in spine surgical procedure. Be taught extra at www.accelusinc.com.

Disclaimer
GE, Medtronic, Ziehm and Stryker will not be affiliated with Accelus and nothing on this press launch is meant to suggest a relationship with, or endorsement or sponsorship of Accelus or its merchandise by, these or every other corporations.

Media Contact:
Brandy Craig
305-676-1679

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