Cionic’s Neural Sleeve 2 wins FDA Clearance, expands mobility options for neurological patients

Cionic launches update to its Neural Sleeve: ©Cionic

Cionic announced that the U.S. Food and Drug Administration has cleared its second-generation wearable neurotechnology, the Neural Sleeve 2, marking a milestone for non-invasive mobility support.

The Neural Sleeve 2 uses AI-driven MultiStim technology to simultaneously activate muscle movement and relax spasms, making it the first FDA-cleared device of its kind. The clearance expands indications to include muscle spasm relaxation, a significant step for patients with conditions such as multiple sclerosis, cerebral palsy, spinal cord injury and stroke. Spasticity affects 97% of stroke survivors with motor deficits and 84% of people with multiple sclerosis, often causing pain, limiting movement and impeding sleep.

“Spasticity is one of the most persistent barriers to mobility, yet it has been neglected for too long,” said Jeremiah Robison, Cionic founder and CEO. “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 sleeve builds on the success of Cionic’s first-generation device, launched in 2023, which has logged more than 2 million hours of real-world use and stimulated 500 million steps. In back-to-back paired tests, 94% of participants showed improved gait, with users reporting a 68% increase in foot clearance, 44% improvement in ankle stability and a 30% reduction in spasticity during home trials.

Designed with fuseproject, the Neural Sleeve 2 integrates advanced features into a form-fitting, clothing-inspired design for all-day wear. Cionic, which partners with 35 clinical, research and advocacy organizations, plans a nationwide rollout of the device.

“It’s been remarkable,” said Barry Singer, director of The MS Center for Innovations in Care at Missouri Baptist Medical Center. “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.”

Advances in mobility technology

The FDA clearance of Cionic’s Neural Sleeve 2 comes amid a wave of innovation in mobility and rehabilitation technologies that is reshaping patient care. Historically, mobility support has relied on tools such as wheelchairs, canes and walkers — devices that have changed little in centuries. Recent developments, however, are opening new possibilities through the integration of artificial intelligence, advanced sensors and wearable systems.

One key advancement has been the ability to personalize therapy in real time. AI-driven devices can now interpret gait patterns, muscle activity and movement challenges, then automatically adapt to the user’s environment, whether walking on flat surfaces, climbing stairs or navigating uneven ground. This shift allows technology not only to support basic movement but also to encourage long-term muscle re-education, helping patients regain function rather than simply compensate for its loss.

Spasticity management has emerged as a particularly important frontier. Long considered an unmet need, technologies are now being designed to both stimulate weak muscles and relax overactive ones, targeting two sides of the same problem. For patients with stroke or multiple sclerosis, this dual approach addresses a barrier that often limits independence and quality of life.

Design is also playing a larger role. Instead of bulky rehabilitation equipment, newer devices are lightweight, discreet and wearable throughout the day. This makes them practical in real-world settings such as work, school or community activities. Patient feedback is increasingly being incorporated into development, resulting in products that are easier to put on, more comfortable to wear and adaptable to different body types.

Clinical validation has kept pace with technological progress. Researchers are collaborating with rehabilitation hospitals and academic centers to ensure new solutions deliver measurable improvements in mobility, endurance and independence. These studies not only demonstrate outcomes but also help establish broader clinical acceptance and reimbursement pathways.

Together, these advances signal a shift from reactive care to proactive, tech-enabled rehabilitation, offering hope that millions of people with neurological conditions may one day achieve greater independence and mobility.