ONWARD Medical Gains FDA Clearance for Home Use of ARC-EX Spinal Stimulation System

The Netherlands-based ONWARD Medical has secured FDA 510(k) clearance to allow its ARC-EX System to be used not only in clinical settings but also in patients’ homes across the United States. The non-invasive platform, designed to improve hand strength and sensation through transcutaneous spinal cord stimulation, is now cleared for individuals with chronic, incomplete spinal cord injuries from C2 to C8.

The ARC-EX System delivers programmed electrical stimulation and is intended to be operated both by rehabilitation professionals and patients or their caregivers at home. Dave Marver, CEO of ONWARD Medical, called the authorization “a defining milestone for the spinal cord injury community,” emphasizing that home-based use will bring greater convenience and access to those living with SCI.

Clinicians also welcomed the change, highlighting the impact on patient care. “For people with limited mobility who navigate daily logistical challenges, having the option to use this therapy at home can make a meaningful difference,” said Dr. Candy Tefertiller of Craig Hospital. Marco Baptista of the Christopher & Dana Reeve Foundation praised the clearance as “an important next step toward expanding multiple avenues of care — and ultimately cures — for people living with spinal cord injury and paralysis.”

ARC-EX Therapy is grounded in a robust body of clinical evidence. A pivotal study published in Nature Medicine showed that 90% of participants experienced improved strength or function, while 87% reported better quality of life. Additional studies have demonstrated sustained benefits over time, including improved sensation, reduced spasms, and better sleep.

Since its commercial launch less than a year ago, the ARC-EX System has been adopted by over 60 clinics in the U.S. The technology was recently recognized by TIME as one of the year’s Best Inventions and featured among Fast Company’s World Changing Ideas for 2025.