Home IMAGING VUZE Medical Announces U.S. FDA 510(K) Clearance for Second-Generation Software-Based 3D Guidance System for Spine Surgery

VUZE Medical Announces U.S. FDA 510(K) Clearance for Second-Generation Software-Based 3D Guidance System for Spine Surgery

VUZE Medical, a privately-held company aiming to transform intra-operative guidance in spinal interventions currently aided only by X-ray, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its second-generation VUZE System. The system’s current focus is on 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 (AR) and traditional hardware-based navigation.

The VUZE System 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 operating room (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 both 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 on the VUZE System itself.

“Our second generation significantly extends the applicability of the VUZE System across desired surgical workflows and operating room setups,” said David Tolkowsky, founder and CEO of VUZE Medical. “In each of those situations, our aim is to preserve the advantages of common X-ray guidance while addressing its shortcomings.”

Over three million1 surgeries for correcting spinal instability and/or deformation, collectively known as spinal stabilizations, are performed annually worldwide, with as many as a third of those1 in the U.S. These procedures include vertebral fixation with pedicle screws, vertebral fixation coupled with fusion, and vertebral augmentation with synthetic or biological cement. The vast majority of stabilizations treat short spinal segments1. Short-segment surgeries are most often assisted only by standard 2D X-ray. The risk of pedicle screw misplacement has been shown to be greater under X-ray guidance than in navigated surgery 2,3.

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