US-based medical technology company Augmedics has secured the US Food and Drug Administration (FDA) 510(k) approval for a new registration method for its xvision Spine System.
The new xvision CT-to-fluoroscopy (CT-Fluoro) registration method allows surgeons to navigate a preoperative CT scan and fluoroscopic images from a standard 2D C-arm.
It will eliminate the need for 3D imaging during surgery, a common barrier in adopting navigation technology.
Also, Augmedics has completed the first surgical case using its new CT-Fluoro registration by Dr Frank Phillips at Rush University Medical Centre in Chicago.
Dr Phillips said: “It was terrific. 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 said the benefits of spine surgery navigation, such as improved accuracy, reduced radiation exposure, and enabling minimally invasive procedures, are well documented.
However, most navigation solutions depend on 3D intraoperative scanning during surgery, which requires expensive and complex systems that most US hospitals may lack.
Augmedics said its new CT-Fluoro registration application builds on the expansion of its unique artificial intelligence (AI) capabilities launched in the Spring of last year.
CT-Fluoro expands its open platform with additional flexibility for imaging and registration, allowing surgeons to support both preoperative CT scans and intraoperative 3D imaging.
Augmedics is planning for a limited launch of xvision CT-Fluoro registration at select sites by the end of this year, with plans for a full commercial launch in the US in Spring 2025.
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. CT-Fluoro enables surgeons to unlock the benefits of AR navigation for patients in any facility.”
Watanabe said: “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.”
