FDA Clears Cionic’s Neural Sleeve 2

Cionic has earned U.S. Food and Drug Administration (FDA) clearance for the second-generation Neural Sleeve 2, a product that facilitates muscle re-education to help rewire walking for people suffering from neurological conditions such as multiple sclerosis, cerebral palsy, spinal cord injury, stroke, and other diagnoses.

The company, which partners with 35 clinical, research, and advocacy organizations, is now selling the Neural Sleeve 2 in the United States. The Neural Sleeve 2 establishes a new benchmark for innovation in the medical device industry by expanding FDA indications to include muscle spasm relaxation. Powered by Cionic’s AI-driven MultiStim technology, it is believed to be 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 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, and simplify wearing it and taking it off.

Together with the Cionic app and dedicated support from expert mobility specialists, the Neural Sleeve 2 offers a comprehensive solution for mobility, allowing its users to improve walking in the moment, adapt to daily life, and achieve 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,” Cionic Founder/CEO Jeremiah Robison said. “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 more than 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.

“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 M.D., director of The MS Center for Innovations in Care at Missouri Baptist Medical Center in St. Louis. “This 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.”

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

• 2 million hours of real-world wear by Neural Sleeve users in two 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
• A 68% increase to foot clearance
• A 44% improvement to ankle stability
• A 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-plus 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

Founded in 2018 and headquartered in San Francisco, Cionic has created an advanced system that combines wearable neurotechnology, adaptive AI, and connected care.