VUZE Medical Announces U.S. FDA 510(k) Clearance for Its VUZE System
VUZE Medical, a privately held medical technology company aimed at transforming image guidance and verification in minimally invasive spine surgeries, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its VUZE™ System. Using proprietary image processing, the VUZE System is a software-only solution that overlays a graphical representation of tools seen in intra-operative 2D images onto axial and sagittal views generated from the patient's standard pre-operative 3D scan. The system is designed for use during common spinal stabilization surgeries that are performed in outpatient or ambulatory settings and are currently aided solely by X-ray.
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The VUZE System's hardware consists only of an on-cart, off-the-shelf PC and the only imaging required in the OR is a standard 2D X-ray. The system uses no sensors, cameras or reference arrays whatsoever, nor does it require any calibrations or lines of site. It can be used with standard surgical tools and implants with no tool add-ons or modifications. The VUZE System offers pre-operative surgical planning including implant sizing, entry location and trajectory determination, along with intra-operative guidance and tool trajectory / position confirmation.
First patient cases with the VUZE System have been performed successfully at Rambam Medical Center in Israel by Drs. Ory Keyman and Elias Haddad. VUZE Medical anticipates first patient cases in the U.S. in mid-2022.
"Our early experience has demonstrated very high surgical accuracy and the VUZE System is proving to be extremely useful," said Dr. Keynan. "Furthermore, we believe that the VUZE System will enable us to perform a broader range of surgeries in a minimally-invasive manner."
More than three million surgeries for correcting spinal instability and/or deformation, collectively known as spinal stabilizations, are performed annually worldwide, with a third of those in the U.S. 1. These procedures include vertebral fixation with pedicle screws, vertebral fixation coupled with fusion, and vertebral augmentation with synthetic or biological cement. Approximately 80 percent of stabilizations treat short spinal segments 1. Short-segment surgeries are most often performed manually and are typically assisted only by standard 2D X-ray.
"VUZE Medical was founded to address a technology gap in guiding short-segment spinal interventions. We are aiming to preserve the advantages of common X-ray guidance while addressing its shortcomings," said David Tolkowsky, VUZE Medical's CEO. "Rising cost pressures and a growing aversion towards hospitalization in the age of COVID-19 are accelerating a shift of short-segment surgeries from inpatient to outpatient and from outpatient to ambulatory settings. In such settings, reliance on X-ray guidance is particularly high. We believe this will be the greatest opportunity for our system."
About VUZE Medical
VUZE Medical is a privately-held medical technology company that aims to provide highly accurate and cost-effective surgical guidance for common spinal interventions currently aided only by standard 2D X-ray alone. The company's VUZE System is a unique software-only solution that instantly merges intra-operative X-ray with pre-operative CT, providing surgeons with the cross-sectional images they need most during surgery and currently lack. The system is designed for use during common spinal surgeries that are performed in outpatient or ambulatory settings. For more information, visit www.vuzemedical.com.
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