FDA Clears Cionic Neural Sleeve 2, Ushering in a New Era in Mobility Care

The second-generation wearable neurotech is the only system to improve walking by simultaneously activating muscle movement and relaxing muscle spasms through AI-powered stimulation

SAN FRANCISCO, Sept. 23, 2025 /PRNewswire/ -- Cionic, the pioneering company behind the first FDA-cleared wearable neurotech for mobility, today announced that the U.S. Food and Drug Administration (FDA) has granted clearance for its second-generation product, the Neural Sleeve 2. This decision marks a major milestone in the company's mission to superpower movement and validates Cionic's system as the most advanced non-invasive technology for supporting mobility. The Neural Sleeve 2 facilitates muscle re-education to help rewire walking for millions of people living with neurological conditions such as multiple sclerosis, cerebral palsy, spinal cord injury, stroke, and other diagnoses. Following FDA clearance, the company, which partners with 35 clinical, research, and advocacy organizations, is launching the Neural Sleeve 2 for patients across the country.

The Neural Sleeve 2 establishes a new benchmark for innovation in the medical device industry, expanding FDA indications to include muscle spasm relaxation. Powered by Cionic's AI-driven MultiStim technology, it is the first and only FDA-cleared device to simultaneously activate muscle movement and relax muscle spasms. With this indication, the Neural Sleeve 2 addresses a long-neglected challenge for people with mobility impairments. Spasticity affects 97% of stroke survivors with motor deficits and 84% of people with multiple sclerosis, limiting movement, causing pain, and impeding sleep. Until now, no wearable solution has effectively targeted this critical barrier to mobility.

Designed in partnership with world-class design agency fuseproject, the Neural Sleeve 2 integrates advanced technology in a sleek, bionic-clothing-inspired form factor for all-day wear at home and in the community. The new design enhances flexibility and sizing to fit more users, inspire confidence from day one, and simplify putting it on and taking it off.

Together with the Cionic app and dedicated support from expert mobility specialists, the Neural Sleeve 2 offers the most comprehensive solution for mobility available today, improving walking in the moment, adapting to daily life, and promoting greater independence over time.

"We are thrilled to launch the Neural Sleeve 2 and reset the standard of mobility care for millions of people with neurological conditions that impact walking," said Jeremiah Robison, Cionic founder and CEO. "Spasticity is one of the most persistent barriers to mobility, yet it has been neglected for too long. By seamlessly integrating functional muscle activation with relaxation of muscle spasms, our new Neural Sleeve has even greater power to transform daily life for our users."

The Neural Sleeve 2 builds upon the success of Cionic's first-generation Neural Sleeve, which launched in 2023. Currently supporting thousands of individuals living with 20+ neurological conditions that affect mobility, the sleeve uses algorithms that adapt to a user's unique gait, and adjust to different speeds and terrains. With the Neural Sleeve, Cionic users are reaching new milestones in their mobility journeys, from exploring their neighborhoods, to navigating professional spaces, to summiting hills and mountains.

"It's been remarkable. My patients using the Neural Sleeve can stay active and accomplish more throughout the day. By contracting their muscles, the device builds muscle strength and walking continues to improve," says Barry Singer MD, Director of The MS Center for Innovations in Care at Missouri Baptist Medical Center in St. Louis. "This breakthrough technology is already making a real difference, with even greater advances ahead." 

The innovations in the Neural Sleeve 2 reflect feedback from current users, as well as Cionic's work with 28 Centers of Excellence, and with research and advocacy partners across the country. Partnerships with leading institutions, such as the Shirley Ryan AbilityLab and Stanford University, ensure the device meets the highest standards of clinical insight and patient care.

"Mobility is fundamental to independence, yet for millions of people nationwide the default solutions are wheelchairs, canes, and walkers — devices that haven't meaningfully changed in centuries," Robison added. "At Cionic, we are building a new operating system for human movement by combining AI, advanced sensing, and stimulation. And we're moving fast: just two years after the launch of our first sleeve, we're releasing our second-generation product, which is proof of the speed and rigor we're bringing to advance this overlooked field."

Facts and Figures
In the three years since Cionic's first FDA clearance, the company has transformed mobility care from concept to proven impact, combining scale, clinical outcomes, and customer adoption at a pace rarely seen in health technology.

• 2 million hours of real-world wear by Neural Sleeve users in just 2 years
• 500 million steps stimulated, proving the Neural Sleeve is a key part of people's daily lives
• 94% of participants demonstrated improved gait in back-to-back paired tests
  • 68% increase to foot clearance
  • 44% improvement to ankle stability
• 30% improvement to spasticity reported by home trial participants using the Neural Sleeve 2, addressing one of the most limiting barriers to safe, independent walking
• 1,500 prescribers nationwide across 20+ diagnoses showing broad clinical applicability for improving mobility
• 35 clinical, research, and advocacy partnerships, including the Shirley Ryan AbilityLab, Stanford University, the University of Washington, National Multiple Sclerosis Society, Multiple Sclerosis Society of America, and others

For more information about Cionic and the Neural Sleeve, please visit http://cionic.com/.

About CIONIC
Founded in 2018 and headquartered in San Francisco, Cionic is pioneering the future of movement through an advanced system that combines wearable neurotechnology, adaptive AI, and connected care. With the FDA-cleared Neural Sleeve 2 at its core, Cionic is setting a new standard for mobility care today and building toward a future where people can move further, faster, and fearlessly, across every limb and every condition.

SOURCE Cionic