VUZE Medical received FDA 510(k) clearance to market its second-generation VUZE System. The system’s current focus is minimally invasive thoracolumbar stabilizations; however, the underlying VUZE technology is not specific to any particular anatomy, and the company intends to seek regulatory clearances for further spinal and skeletal interventions in the future.
VUZE has already received eleven related patents in the U.S., Europe, China and India, including tie-ins with robotics, augmented reality and traditional hardware-based navigation.
VUZE is a software solution installed on an off-the-shelf PC. It operates with unmodified surgical tools, uses no markers, references or cameras, and makes 3D imaging in the OR entirely optional. Using proprietary image processing algorithms, it overlays in real time graphical representations of standard surgical tools seen in intra-operative 2D X-ray images onto axial and sagittal cross-sections that it generates from the patient’s standard pre-operative 3D scan. The VUZE System received its initial U.S. FDA 510(k) clearance in 2022 and completed a first-in-human clinical trial in 2023.
The second-generation VUZE System supports a far broader range of surgical C-arms from all major vendors. Additionally, it accommodates more sources of 3D image data, including standard pre-operative CT and in-OR CT/CBCT scans. Its expanded functionality includes the ability to perform surgical planning at any time or place on a compatible standalone laptop in addition to the VUZE System itself.
VUZE Medical received FDA 510(k) clearance to market its second-generation VUZE System. The system’s current focus is minimally invasive thoracolumbar stabilizations; however, the underlying VUZE technology is not specific to any particular anatomy, and the company intends to seek regulatory clearances for further spinal and skeletal...
VUZE Medical received FDA 510(k) clearance to market its second-generation VUZE System. The system’s current focus is minimally invasive thoracolumbar stabilizations; however, the underlying VUZE technology is not specific to any particular anatomy, and the company intends to seek regulatory clearances for further spinal and skeletal interventions in the future.
VUZE has already received eleven related patents in the U.S., Europe, China and India, including tie-ins with robotics, augmented reality and traditional hardware-based navigation.
VUZE is a software solution installed on an off-the-shelf PC. It operates with unmodified surgical tools, uses no markers, references or cameras, and makes 3D imaging in the OR entirely optional. Using proprietary image processing algorithms, it overlays in real time graphical representations of standard surgical tools seen in intra-operative 2D X-ray images onto axial and sagittal cross-sections that it generates from the patient’s standard pre-operative 3D scan. The VUZE System received its initial U.S. FDA 510(k) clearance in 2022 and completed a first-in-human clinical trial in 2023.
The second-generation VUZE System supports a far broader range of surgical C-arms from all major vendors. Additionally, it accommodates more sources of 3D image data, including standard pre-operative CT and in-OR CT/CBCT scans. Its expanded functionality includes the ability to perform surgical planning at any time or place on a compatible standalone laptop in addition to the VUZE System itself.
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