SpineVision Receives FDA Clearance for PediGuard

SpineVision has received FDA clearance to market its PediGuard instrument as an FDA Class II device, making it the first and only FDA-cleared device for real-time detection of possible penetration outside the vertebral pedicle, the company said.

Accuracy of pedicle screw placement is still an issue in spine surgery. PediGuard is the first patented, wireless, handheld instrument capable of accurately detecting changes in tissue type, alerting surgeons to potential pedicular or vertebral breaches during pedicle screw site preparation. Real-time feedback is provided to surgeons via audio and visual signals, giving them new additional information. The use of PediGuard requires no change in surgical technique.

As part of the FDA clearance process, a successful multicenter study involving PediGuard was completed. The results of this study were published in European Spine Journal.