SpineGuard received FDA clearance on the PediGuard products for minimally invasive spine surgery.
There are around 1 million spine surgeries using pedicle screws performed annually worldwide around 15 percent to 20 percent are done through less invasive approaches. The cannulated PediGuard expands pedicle screw placement applicability with real-time feedback using the Dynamic Surgical Guidance technology.
The system also reduces radiation exposure for the surgeons and hospital staff.
"This is an especially important regulatory milestone for SpineGuard as it will allow us to promote the use of PediGuard in the United States for minimally invasive pedicle screw placement, one of the fastest growing market segments in spine surgery," says CEO and Co-founder Pierre Jerome. "It also further strengthens our U.S. regulatory position as we prepare the submission for dynamically guided screws."