Cionic's Neural Sleeve 2 Gains FDA Clearance for Enhanced Mobility Care

September 23, 2025
Cionic has received FDA clearance for its Neural Sleeve 2, a wearable device that improves mobility by activating and relaxing muscles through AI-powered stimulation.

Cionic has announced that the U.S. Food and Drug Administration (FDA) has granted clearance for its second-generation product, the Neural Sleeve 2. Announced in a press release, this wearable neurotech device is designed to enhance mobility by simultaneously activating muscle movement and relaxing muscle spasms through AI-powered stimulation.

The Neural Sleeve 2 is the first FDA-cleared device to offer this dual functionality, addressing a significant challenge for individuals with mobility impairments such as those caused by multiple sclerosis, cerebral palsy, and stroke. The device uses Cionic's AI-driven MultiStim technology to facilitate muscle re-education, helping to rewire walking patterns for millions of people living with neurological conditions.

Following the FDA clearance, Cionic is launching the Neural Sleeve 2 across the United States. The device, designed in collaboration with the design agency fuseproject, features a sleek, bionic-clothing-inspired form factor for all-day wear. It integrates with the Cionic app and offers support from expert mobility specialists, providing a comprehensive solution for improving walking and promoting greater independence over time.

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