Neural Sleeve 2 facilitates muscle re-education to help rewire walking for people with neurological conditions. Those conditions may include multiple sclerosis, cerebral palsy, spinal cord injury, stroke and more. With FDA clearance in hand, the company plans to begin launching the new product across the country.
FDA clearance for the latest Neural Sleeve offering comes more than three-and-a-half years after the company’s first FDA clearance in March 2022. Data shared as recently as last year demonstrated significant improvements in gait for those with multiple sclerosis.
San Francisco-based Cionic says the solution establishes a new benchmark, expanding its indications to include muscle spasm relaxation. Using AI-driven MutliStim technology, the device simultaneously activates muscle movement and relaxes muscle spasms.