The device was developed in partnership with Omnia Medical, according to a Sept. 30 news release. Clearance will help deploy SpineGuard’s Dynamic Surgical Guidance technology in the U.S.
“We’ve seen that proper placement of the implant is essential to a successful SI joint fusion,” Troy Schifano, CEO and co-founder of Omnia Medical, said in the release. “Locating the joint is critical for this to occur but can be very challenging. However, the data SpineGuard provided to the FDA during the clearance process has confirmed PsiFGuard drastically enhances the accuracy of the placement of the wire guiding the implant.”
