Vuze Medical has submitted a 510(k) filing with the US Food and Drug Administration (FDA) for VUZE 2.0—a new, second-generation, investigational version of its VUZE system that is set to feature prominently at the 38th annual meeting of the North American Spinal Society (NASS; 18–21 October, Los Angeles, USA).
The VUZE system is a software solution installed on an off-the-shelf computer. It operates with unmodified surgical tools, requiring no markers, references or cameras, and with no need for 3D imaging within the operating room (OR), according to a recent Vuze press release.
Using proprietary image processing, the system overlays in real time graphical representations of standard surgical tools seen in intraoperative 2D X-ray images onto axial and sagittal cross-sections that it generates from the patient’s standard preoperative 3D scan. The VUZE system previously received US FDA 510(k) clearance in 2022 and completed a successful first-in-human clinical trial in early 2023. Vuze claims to have received eight related patents to date in the USA, Europe and Asia.
Attendees of NASS 2023 will have the opportunity to observe the investigational VUZE 2.0 in cadaveric surgery in a Surgical Stadium session titled “Navigated MISS [minimally invasive spinal surgery] with no tool modifications, references, markers or cameras” on 19 October. Hands-on experimentation will also be available at a cadaveric workshop on the same day. Further information will be provided at the Vuze booth (#1051). In addition, clinical experience will be reviewed in a Red Theater presentation, “A new approach to guidance and verification in MISS: results of first-in-human trial with the VUZE system”, on 20 October.
The second-generation VUZE system is designed to support a broader range of surgical C-arms from multiple vendors and accommodate more sources of 3D image data, including both preoperative computed tomography (CT) and in-OR 3D scans. It also aims to provide expanded functionality, including the ability to perform surgical planning on a standalone laptop in addition to on the VUZE system.
“Our second generation aims to extend the operability of the VUZE system across a much larger percentage of operating rooms,” said David Tolkowsky, founder and CEO of Vuze. “The new features and functionality could, once cleared by FDA, make VUZE more accessible and provide surgeons with more effective guidance in situations where they previously did not have many attractive options.”