ONWARD Medical received CE Mark certification for its ARC-EX System on September 8, 2025, allowing the company to market the device in the European Union and other countries that recognize CE marking.
ARC-EX is a non-invasive spinal-cord stimulation system designed to improve hand strength and sensation in people with chronic spinal cord injury. The device delivers programmed transcutaneous electrical stimulation through electrodes placed on the back of the neck and is intended for use alongside functional task practice.
Why it matters
The certification is an early example of a non-invasive neuromodulation product moving into commercial use in Europe and provides a regulatory reference for similar devices.