SpineGuard has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its PediGuard products for Minimally Invasive Surgery (MIS).
PediGuard is said to be the only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. It was co-invented by Maurice Bourlion, Ciaran Bolger and Alain Vanquaethem.
SpineGuard CEO and co-founder Pierre Jérôme said: "This is an especially important regulatory milestone for SpineGuard, as it will allow us to promote the use of PediGuard in the US for minimally invasive pedicle screw placement, one of the fastest growing market segments in spine surgery.
"It also further strengthens our US regulatory position as we prepare the submission for dynamically guided screws."
The device provides real-time feedback through audio and visual signals, and around 35,000 procedures have been performed with PediGuard across the world, noted SpineGuard.
According to the company, MIS has been developed to treat disorders of the spine with less disruption to the muscles and allow patients to recover rapidly and return to normal function post operation.