The ARC-EX System is the world's first FDA-approved non-invasive spinal cord stimulation system for chronic spinal cord injury. It delivers programmed transcutaneous electrical stimulation to the cervical spinal cord via skin electrodes on the back of the neck, improving hand sensation and strength when used with functional task practice. In the Up-LIFT clinical trial (65 participants, 14 SCI centers), 90% improved upper limb strength or function, 87% reported quality of life improvement, with benefits demonstrated up to 34 years post-injury. Selected as TIME Magazine Best Invention 2024 and Fast Company 2025 World Changing Ideas.
This device does not have a current FDA designation. It may be a research tool, preclinical device, or consumer product not subject to FDA medical device regulation.
FDA Device Regulatory Guidance ↗