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New medical device designed to help people with neurological issues improve walking

Neural Sleeve gets FDA clearance
Neural Sleeve gets FDA clearance
Posted at 6:18 PM, Mar 08, 2022
and last updated 2022-03-08 18:30:55-05

CLEVELAND — The Federal Drug Administration just gave clearance for a new medical device designed to help people with mobility issues. Neural Sleeve has been granted FDA clearance for functional electrical stimulation to assist in gait for people with foot drop and leg muscle weakness.

“Anyone that has a neurological disease or condition or injury. It’s really going to range from individuals with MS, stroke, we also see incomplete spinal cord,” said Brian Kolonick, Cionic Vice President Strategies and Business Development.

The goal is to improve the ability to walk for people with mobility issues. It works by functional electrical stimulation.

“With typical gait, individuals receive signals from the brain that activates their muscles; for folks with stroke, Parkinson’s, Cerebral Palsy, MS, their brains are no longer ably communicating to their muscles so they can fire in a coordinated fashion, and so our device replaces the function of the brain as it pertains to gait and activates the muscles automatically,” said Jon Sakai, Cionic Director of Commercialization.

Dozens of people in Cleveland and San Francisco took part in the study.

John Pumper was one of them. He had a stroke at just 45 years old. He lost some movement in his right arm and leg. Pumper is excited about the new technology.

“It shows a lot of potential,” he said.

The device requires a doctor's prescription. More information is available at

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