InVivo Therapeutics Receives FDA Approval for Pivotal, Randomized, Controlled Trial of the Neuro-Spinal Scaffold in Patients with Acute Spinal Cord Injury

Study Designed to Enhance Clinical Evidence from INSPIRE Study and Support Potential Humanitarian Device Exemption (HDE) Submission


A Humanitarian Device Exemption is an approval process provided by the United States Food and Drug Administration allowing a medical device to be marketed without requiring evidence of effectiveness. The FDA calls a device approved in this manner a "Humanitarian Use Device" (HUD)