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  1. VUZE Medical Announces U.S. FDA 510(K) Clearance for Second …

  2. VUZE Medical Announces U.S. FDA 510(K) Clearance for Second …

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    VUZE Medical is a privately-held medical technology company that aims to provide highly accurate and cost-effective surgical guidance for common skeletal interventions currently aided only by standard 2D X-Ray, with a current focus on spine.
    RA’ANANA, Israel, May 29, 2024 -- ( BUSINESS WIRE )-- 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 company’s VUZE System is a unique software-based solution that instantly merges intra-operative X-ray with pre-operative CT or CBCT, providing surgeons with the cross-sectional images they need most during surgery and traditionally lack. The system is targeted primarily at outpatient and ambulatory settings.
    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.
    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.
    VUZE 2.0 provides much-extended interoperability and functionality; like VUZE 1.0, requires only a 2D C-arm and PC in the OR -- no cameras, markers, references or tool add-ons
  4. VUZE Medical Announces U.S. FDA 510(K) Clearance for Second

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