STAT+: FDA OK's novel device for non-invasive treatment of spinal cord injuries

Spinal cord injuries dramatically reduce a person’s mobility and independence, but a new device could aid rehabilitation efforts.

Onward Medical received Food and Drug Administration clearance on Thursday for their non-invasive spinal cord stimulator, the ARC-EX. In a recent trial, the stimulator boosted hand sensation and strength in 72% of participants. While the treatment cannot replace rehabilitative therapy, device users rave about its effects. The agency first designated the system as a “breakthrough device” in 2021.

“They tell patients the golden window of recovery is that first year or two,” said Sherown Campbell, one of the trial participants who signed up after he broke his neck wrestling in 2014. “I’ve made significant progress since then. I didn’t think that I would be able to move as much as I do, or I guess, as close to normal as I am.”

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