SpineGuide Technologies Receives U.S. FDA Breakthrough Device Designation for CurvRITE System in Treating Patients with EOS
St Paul, Minnesota, September 11, 2023 —- SpineGuide Technologies, a global medical device company, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its CurvRITE System to treat Children with Early Onset Scoliosis (EOS). The Breakthrough Device program is intended to expedite the process of bringing to market devices. The benefits of the program include priority review for regulatory submissions and the opportunity for regular and interactive engagement with the FDA to facilitate the efficient clinical and technical development of the device.
