FDA 510(k) Clearance

ONWARD Medical’s ARC-EX System received FDA clearance for supervised home use, expanding its indication for adults with incomplete spinal cord injury (C2–C8) to improve hand strength and sensation. ARC-EX delivers transcutaneous spinal cord stimulation and is intended for both clinical and home use. Clinical evidence, including the Up-LIFT study, showed significant improvements in strength, function, and quality of life. The system is commercially available in over 60 US clinics. This clearance marks a significant step in expanding access to SCI rehabilitation.