Medical augmented reality developer Augmedics has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new registration method for the company's xvision Spine System.
The xvision CT-to-fluoroscopy (CT-Fluoro) registration method allows surgeons to navigate off a preoperative CT scan and fluoroscopic images from a standard 2D C-arm. This eliminates the need for 3D intraoperative imaging.
Augmedics also highlighted the successful completion of the first surgical case using its new registration by Rush University Medical Center in Chicago, IL. CT-Fluoro's applications stem from an expansion of Augmedics' proprietary AI features launched in 2023. CT-Fluoro also builds on Augmedics’ open platform with additional imaging and registration flexibility. This allows surgeons to choose between preoperative CT and intraoperative 3D imaging and registration.
Augmedics said it is conducting a limited launch of xvision’s CT-Fluoro registration at select sites through the end of 2024 and plans a full commercial launch to the U.S. market in spring 2025.
