ONWARD Medical Receives FDA 510(k) Clearance Expanding ARC-EX System Indication for Home Use

ONWARD Medical announced it has received FDA 510(k) clearance allowing the ARC-EX System to be used at home by people with spinal cord injuries16.

The ARC-EX System is notable as the first and only FDA-cleared technology shown to improve hand strength and sensation in people with spinal cord injury (SCI)36.

Prior to this clearance, the system was indicated for use primarily in clinical settings. The new clearance significantly broadens access by allowing home use16.

The ARC-EX System delivers non-invasive, transcutaneous electrical stimulation to the spinal cord and is supported by significant clinical data, including the Up-LIFT pivotal trial, which showed improved hand function and quality of life in participants with chronic incomplete tetraplegia3.

In parallel to the US clearance, ONWARD Medical has also filed for CE Mark certification to enable commercialization in the European Union and countries recognizing CE Marking24.

The expansion of the ARC-EX home use indication aligns with ONWARD Medical’s mission to improve accessibility and outcomes for people with SCI globally12.

Sources:

1. https://www.marketscreener.com/news/onward-medical-n-onward-medical-receives-fda-510-k-clearance-expanding-arc-ex-system-indication-f-ce7d5edad98ff721

2. https://live.euronext.com/en/products/equities/company-news/2025-07-01-onward-medical-files-510k-us-fda-arc-ex-system-home-use

3. https://www.onwd.com/therapy/arc-ex/

4. https://trial.medpath.com/news/68d8d3c4a8050f25/onward-medical-submits-fda-510-k-application-for-home-use-of-arc-ex-spinal-cord-stimulation-system

6. https://ca.investing.com/news/company-news/fda-clears-onwards-arcex-system-for-home-use-in-spinal-cord-injury-93CH-4320217