Augmedics has received U.S. Food and Drug Administration (FDA) 510(k) clearance for a new registration method for its xvision Spine System, the xvision CT-to-fluoroscopy (CT-Fluoro) method.

This method lets surgeons navigate off a pre-op CT scan and fluoroscopic images from a standard 2D C-arm. This, in turn, removes the need for 3D intraoperative imaging, which is a common barrier to adoption of navigation.

Augmedics also successfully completed the first surgical case using CT-Fluoro registration. It was completed by Dr. Frank Phillips at Rush University Medical Center in Chicago, who also completed the world’s first augmented reality (AR)-navigated, minimally invasive spine surgery in June 2020.

“It was terrific,” said Dr. Phillips. “It’s so much more efficient than bringing in the 3D scanner and the quality of the 2D and 3D visualization 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 visualization 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.”

More access for AR navigation

Today, most navigation solutions depend on a 3D intra-op scan of anatomy taken during surgery. However, the 3D imaging systems that create these scans can be expensive, unwieldy, and scarce. Augmedics said data suggests that over half of U.S. hospitals don’t have access to these machines.

The foundation of CT-Fluoro rest on an expansion of the company’s artificial intelligence (AI) capabilities launched in spring 2023. It also builds on Augmedics’ open platform with further imaging and registration flexibility so surgeons can choose between pre-op CT and intra-op 3D imaging and registration.

Augmedics is conducting a limited launch of xvision’s CT-Fluoro registration at select sites through the end of the year and plans a full commercial launch to the U.S. market in spring 2025.

“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,” Watanabe went on. “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.”