The Food and Drug Administration has green-lit home use of a device that helps people with spinal cord injuries regain mobility and functioning. Onward Medical announced Monday that the company had received clearance to expand the use of its spinal cord stimulator outside of clinics.
“People living with [spinal cord injuries] will now be able to benefit from use of the ARC-EX System in the comfort and convenience of their own homes,” said CEO Dave Marver in a press release.
FDA first cleared the device for clinical use in 2024, after designating it a breakthrough device. An earlier trial demonstrated that small zaps delivered on the skin and along the spine boosted hand and arm function in 72% of participants when paired with rehabilitative therapy. No serious adverse outcomes were reported.
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