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New Imaging Software Gets FDA Clearance for Use in Short-Segment Spine Stabilization


As a potential complement to intraoperative X-rays, the imaging software may be beneficial for short-segment spine procedures performed in outpatient or ambulatory surgery centers.

Could an emerging software enhance intraoperative radiographs during short-segment spinal stabilization procedures?

The VUZE System, which recently garnered 510(k) clearance from the Food and Drug Administration (FDA), is a software that shows key cross-sectional views that are not attainable with the standard two-dimensional X-rays often employed by surgeons during surgeries to address short-segment spinal stabilization.

With availability from an on-cart, off-the-shelf PC, the VUZE System employs proprietary image processing to overlay a representation of tools shown on intraoperative 2D X-rays onto axial and sagittal images from a standard preoperative computed tomography (CT) scan, according to the manufacturer VUZE Medical.

Reportedly, more than 800,000 surgeries are performed annually in the United States to repair short spinal segments. David Tolkowsky, the CEO of VUZE Medical, said the VUZE System can be a key adjunct to intraoperative X-rays obtained during procedures that involve pedicle screw fixation, fusion, or vertebral augmentation with biological or synthetic cement.

“We are aiming to preserve the advantages of common X-ray guidance while addressing its shortcomings,” noted Tolkowsky. “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 high.”

Utilizing no cameras, sensors nor reference arrays, the VUZE System can be employed with standard surgical tools and implants without modifications or add-ons, according to VUZE Medical. In addition to intraoperative guidance, VUZE Medical said the software facilitates pre-op planning regarding implant sizing, entry location and trajectory determination.

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