FDA clears Vuze System update

Vuze Medical has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its second-generation Vuze System.

VUZE System is a software-based 3D guidance system for spine surgery. It uses image processing to overlay graphical representations of surgical tools on intraoperative 2D x-ray images onto a patient's preoperative CT scan. The new version provides extended interoperability and functionality, including:

  • Support for a far broader range of surgical C-arms from all major vendors
  • Accommodates more sources of 3D image data including both standard pre-operative CT and in-OR CT/CBCT scans
  • The ability to perform surgical planning at any time or place on a compatible standalone laptop, in addition to on the VUZE System itself

The system’s current focus is on minimally invasive thoracolumbar stabilizations. The company said it intends to seek regulatory clearances for further spinal and skeletal interventions in the future.

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