SpineX’s Pediatric Spinal Device Receives FDA Breakthrough Device Designation

Los Angeles, Calif.-based SpineX’s SCiP (spinal cord innovation in pediatrics) system has received the FDA’s Breakthrough Device designation for treatment of cerebral palsy in children.

SCiP is a noninvasive spinal electrical neuromodulation device that provides transcutaneous spinal cord stimulation to treat the underlying cause of the condition. The device has “shown great promise in early clinical feasibility studies,” the company said.

SpineX previously received the FDA’s Breakthrough Device designation for a neuromodulation device for treatment of neurogenic bladder, an incurable condition in which the relationship between the nervous system and bladder function is disrupted by injury or disease.