Rachel Klemovitch, Assistant Editor05.29.24
VUZE Medical has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its second-generation VUZE System. The system focuses on minimally invasive thoracolumbar stabilizations.
The 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. The VUZE System received its initial U.S. FDA 510(k) clearance in 2022 and completed a first-in-human clinical trial in 2023.
“Our second generation significantly extends the applicability of the VUZE System across desired surgical workflows and operating room setups,” said VUZE Medical founder and CEO, David Tolkowsky. “In each of those situations, our aim is to preserve the advantages of common X-ray guidance while addressing its shortcomings.”
The VUZE System can be installed on a PC and operates with unmodified surgical tools, uses no markers, references, or cameras, and makes 3D imaging in the operating room (OR) entirely optional.
The system uses image processing algorithms to overlay real-time graphical representations of standard surgical tools seen in intra-operative 2D X-ray images onto axial and sagittal cross-sections generated from the patient’s standard pre-operative 3D scan.
VUZE has 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 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. The VUZE System received its initial U.S. FDA 510(k) clearance in 2022 and completed a first-in-human clinical trial in 2023.
“Our second generation significantly extends the applicability of the VUZE System across desired surgical workflows and operating room setups,” said VUZE Medical founder and CEO, David Tolkowsky. “In each of those situations, our aim is to preserve the advantages of common X-ray guidance while addressing its shortcomings.”
The VUZE System can be installed on a PC and operates with unmodified surgical tools, uses no markers, references, or cameras, and makes 3D imaging in the operating room (OR) entirely optional.
The system uses image processing algorithms to overlay real-time graphical representations of standard surgical tools seen in intra-operative 2D X-ray images onto axial and sagittal cross-sections generated from the patient’s standard pre-operative 3D scan.
VUZE has 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.