FDA approves home use of new system for spinal cord injury
The US FDA approves the home use of Onward Medical's spinal cord stimulation system.
Published on November 17, 2025
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Onward Medical announced on Monday morning that the US FDA has approved the ARC-EX system for home use. The system helps adults with incomplete spinal cord injuries to improve their hand strength and sensation. It uses spinal cord stimulation to improve arm and hand function, enabling them to use their limbs again.
The FDA has approved the ARC-EX system for use in clinics and at home. The system helps adults with incomplete spinal cord injuries improve their hand strength and sensation. ARC-EX is non-invasive and uses electrical stimulation through the skin. It can be used by rehabilitation professionals in healthcare facilities and by patients themselves at home, possibly with the help of a caregiver.
Clinical evidence
ARC-EX therapy is supported by a unique amount of clinical evidence. Results published in Nature Medicine show that 90% of participants saw improvements in strength or function, 87% reported an improvement in quality of life, and benefits were observed up to 34 years after the injury. Participants also reported fewer muscle spasms, better sleep quality, and improved sensitivity in the upper body, including tactile sensation.
Commercially available for less than a year, the ARC-EX system is now accessible in more than 60 clinics in the United States.