FDA Clears Updated 3D Imaging Guidance for Spine Surgery

The Food and Drug Administration (FDA) has granted 510(k) clearance for a second-generation update of the VUZE System, which overlays positioning of surgical tools from intraoperative X-rays onto cross-sectional, pre-operative computed tomography (CT) scans.

VUZE Medical, the manufacturer of the VUZE System, emphasized that the new version of the software can be utilized with a larger range of surgical C-arm devices. The company added that the updated VUZE system may incorporate 3D imaging source data from cone-beam CT scans obtained in the operating room as well as pre-operative CT imaging.

Expanded functionality with the second-generation version of the software also enables surgical planning on compatible standalone laptops, according to VUZE Medical.

“Our second generation significantly extends the applicability of the VUZE System across desired surgical workflows and operating room setups,” said David Tolkowsky, the founder and CEO of VUZE Medical. “In each of those situations, our aim is to preserve the advantages of common X-ray guidance while addressing its shortcomings.”

While noting a current focus of the VUZE System in facilitating minimally invasive thoracolumbar stabilizations, VUZE Medical said it plans to pursue additional clearances for spinal and skeletal interventions.