SpineGuide Technologies, a global medical device company, announced today that the company has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its CurvRITE System to treat Children with Adolescent Idiopathic Scoliosis (AIS), after receiving Breakthrough Device Designation for Early Onset Scoliosis (EOS) three days ago.
The Breakthrough Device program is intended to expedite the process of bringing to market devices. Since the program started in late 2016, only 101 devices in orthopedic have received the designation as of June 2023. SpineGuide's CurvRITE System has received Breakthrough Device Designation for two separates indications which are EOS and AIS.
https://www.linkedin.com/pulse/spineguide-technologies-receives-us-fda-breakthrough-device-1c