Onward Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance to expand the ARC-EX system’s indication for home use in the U.S.

The ARC-EX system was cleared for use in conjunction with functional task practice in the clinic and take-home exercises to improve hand strength and sensation in adults with chronic, non-progressive neurological deficits from an incomplete spinal cord injury (SCI—C2-C8 inclusive).

ARC-EX is non-invasive and delivers programmed transcutaneous electrical spinal cord stimulation (SCS). It’s intended to be operated in medical centers by rehabilitation professionals and at home by the patient and people offering help to patients as needed.

Dr. Candy Tefertiller, PT, DPT, PhD, NCS, Executive Director of Research and Evaluation at Craig Hospital in Denver, Colorado said she’s excited to see the innovative SCI rehab technology now available for home use.

“For people with limited mobility who navigate daily logistical challenges, having the option to use this therapy at home can make a meaningful difference,” Dr. Tefertiller told the press. “Integrating in-clinic and at-home therapy may help support and maintain improvements in hand strength and sensation, contributing positively to overall quality of life.”

The ARC-EX system was granted CE mark certification in September of this year. The company was also granted FDA IDE approval to begin a study of its implantable ARC-IM system for blood pressure instability after an SCI in September.

“[This] authorization expanding the ARC-EX system indication for home use greatly enlarges the US market opportunity and is a defining milestone for the spinal cord injury community,” said Dave Marver, CEO of Onward Medical. “People living with SCI will now be able to benefit from use of the ARC-EX system in the comfort and convenience of their own homes.”