Onward's Arc-Ex spinal cord stimulator earned the FDA's de novo classification and U.S. market authorization, according to a Dec. 19 news release.
The Arc-EX system is now the first non-invasive spinal cord stimulator to have FDA approval. It is designed for chronic spinal cord injuries and doesn't require surgery to use.
The device, which can help improve hand strength and sensation, is expected to be authorized for at-home use in mid-2025.