Spineguide Technologies, a start-up medical device company, today announced the successful completion of its Q-Submission meeting with the U.S. Food and Drug Administration (FDA) for CurvRITE for the treatment of early onset scoliosis (EOS) and adolescent idiopathic scoliosis (AIS).
The purpose of the meetings was to discuss and confirm the company's regulatory pathway and clinical plan. FDA confirmed that no additional animal studies outside of those already conducted are needed to support a future marketing submission.