Onward Medical has submitted its ARC-EX spinal cord stimulation system for expanded FDA 510(k) clearance to enable home use, while also filing for CE mark approval under EU MDR.
The Eindhoven, Netherlands–based company aims to broaden ARC-EX’s indication beyond clinical settings, allowing patients with spinal cord injury (SCI) to use the non-invasive, transcutaneous system at home. ARC-EX delivers targeted electrical stimulation via electrodes on the neck to improve upper limb function.
Initially cleared by the FDA in December 2024, Onward began commercial U.S. sales earlier this year. The submissions follow positive one-year results from the Pathfinder 2 study, showing functional gains when combining ARC-EX with activity-based rehabilitation.
“Expanding regulatory approval will improve access and grow the market for people living with SCI,” said CEO Dave Marver.
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