Augmedics, an augmented reality (AR) surgical navigation firm, has received US Food and Drug Administration (FDA) 510(k) clearance of a new registration method for its xvision Spine System.
The xvision Spine System gives surgeons X-ray vision to see patient anatomy and navigate instruments and implants during spine surgeries.
Augmedics said the FDA-cleared xvision has been used in over 8,500 patient cases and has assisted in implanting more than 45,000 pedicle screws across 25 US states.
In March this year, the AR surgical navigation firm launched new features and new indications for its xvision Spine System.
The xvision CT-to-fluoroscopy (CT-Fluoro) registration method allows surgeons to use preoperative CT scans and 2D fluoroscopic images from a standard 2D C-arm. This eliminates the need for 3D intraoperative imaging, a key barrier to navigation adoption.
Augmedics also announced the successful completion of the first surgery using its new CT-Fluoro registration method. Frank Phillips at Rush University Medical Center in Chicago performed the procedure.
Phillips said: “It’s so much more efficient than bringing in the 3D scanner and the quality of the 2D and 3D visualisation during navigation was unparalleled.
“The evolution of the technology since our first cases is incredible. The ability to navigate off a preoperative CT that is converted to real time visualisation with two intraoperative fluoroscopic images provides a simple, elegant solution for surgeons who want to bring AR navigation into their workflow without the need for 3D imaging.”
Augmedics’ CT-Fluoro registration application is built on the company’s expanded artificial intelligence (AI) capabilities, introduced in Spring 2023.
The technology also enhances Augmedics’ open platform, offering greater imaging and registration flexibility. Surgeons can now choose between preoperative CT scans and intraoperative 3D imaging and registration.
Augmedics interim CEO Gwen Watanabe said: “Our mission at Augmedics is to bring the proven benefits of navigation to as many surgeons and as many patients as possible.
“By removing the 3D imaging requirement, we’re removing a major barrier to adoption.”
Augmedics is conducting a limited launch of xvision’s CT-Fluoro registration at select sites through the end of the year. A full commercial launch to the US market is planned for Spring 2025.
