The FDA cleared the CT-to-fluoroscopy (CT-Fluoro) registration method for Augmedics’ Xvision Spine System. The device uses augmented reality to give surgeons “X-ray vision” during surgery. It launched new, FDA-cleared features and indications for the system in March. This latest addition enables surgeons to navigate off a preoperative CT scan and fluoroscopic images from a standard 2D C-arm. That eliminates the need for 3D intraoperative imaging.
Augmedics also reported the first surgical case completed using this new registration. Dr. Frank Philips completed this case at Rush University Medical Center in Chicago. Philips previously completed the world’s first augmented reality-navigated minimally invasive spine surgery in 2020.
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The company said the foundations of its CT-Fluoro registration application rest on an expansion of its proprietary AI capabilities launched in 2023. It also builds on its open platform with additional imaging and registration flexibility. That allows surgeons to choose between pre-op CT and intraoperative 3D imaging and registration.
Augmedics plans to conduct a limited launch for the new registration at select sites through the end of 2024. It earmarked spring 2025 for a full U.S. launch.
“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,” said Gwen Watanabe, Augmedics Interim CEO. “CT-Fluoro enables surgeons to unlock the benefits of AR navigation for patients in any facility.
“The beauty of our platform is that it puts the surgeon fully in the driver’s seat. With Augmedics, surgeons can choose the instruments, implants – and now imaging – to best fit the needs of each patient and deliver the best outcomes possible.”
