FDA approves Onward Medical spinal cord stimulator for home use

O. Rose Broderick reports on the health policies and technologies that govern the lives of people with disabilities. Before coming to STAT, she worked at Radiolab and WNYC’s Scientific American, and her story debunking a false theory about transgender children was nominated for a 2024 GLAAD Media Award. You can reach Rose on Signal at rosebroderick.11.

The Food and Drug Administration has given the green light to home use of a device that helps people with spinal cord injuries regain mobility and function. Onward Medical announced Monday that the company had received approval to expand use of its spinal cord stimulator outside of clinics.

“People living with (spinal cord injuries) will now be able to benefit from using the ARC-EX system in the comfort and convenience of their own homes,” CEO Dave Marver said in a news release.

The FDA first cleared the device for clinical use in 2024, after designating it as a breakthrough device. A previous trial showed that small blows applied to the skin and along the spine improved hand and arm function in 72% of participants when combined with rehabilitation therapy. No serious adverse outcomes were reported.