VUZE system gets US FDA 510(k) clearance

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VUZE system

VUZE Medical has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its VUZE system—a software-only solution that overlays a graphical representation of tools seen in intra-operative 2D images onto axial and sagittal views generated from a patient’s standard pre-operative 3D scan. 

The system is designed for use during common spinal stabilisation surgeries that are performed in outpatient or ambulatory settings and are currently aided solely by X-ray.

The VUZE system’s hardware consists of an on-cart, off-the-shelf PC, and the only imaging required in the operating room is a standard 2D X-ray. The system uses no sensors, cameras or reference arrays, nor does it require any calibrations or lines of site and it can be used with standard surgical tools and implants with no tool add-ons or modifications, say the company.

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.

The first patient cases using the system were successfully performed at Rambam Medical Center (Haifa, Israel) by Ory Keynan and Elias Haddad. VUZE Medical anticipates first patient cases in the US in mid-2022.

“Our early experience has demonstrated very high surgical accuracy and the VUZE system is proving to be extremely useful,” said Keynan. “Furthermore, we believe that the VUZE system will enable us to perform a broader range of surgeries in a minimally-invasive manner.”

David Tolkowsky, VUZE Medical’s CEO, added: “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.

“Rising cost pressures and a growing aversion towards hospitalisation 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.”


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