VUZE Medical Gains FDA 510(k) for Spinal Surgery Software

By Julie A. Vetalice

VUZE Medical Gains FDA 510(k) for Spinal Surgery Software

VUZE Medical received FDA 510(k) clearance to market the 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.

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. VUZE 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 in Israel. The company anticipates first patient cases in the U.S. in mid-2022.

“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.”

Source: VUZE Medical

Product Labels: Surgical Navigation

Tags: 510(k) Clearance, Regulatory