Cionic Neural Sleeve 2 Approved by FDA: A Leap Forward for Mobility Innovations

On September 23, 2025, Cionic made a groundbreaking announcement as they received FDA clearance for their latest product, the Neural Sleeve 2. This marks a significant advancement in the realm of wearable neurotechnology aimed at enhancing mobility for people suffering from various neurological conditions. As the only FDA-cleared device specifically designed to address both muscle activation and relaxation, the Neural Sleeve 2 represents a vital step forward in mobility care.

What is the Neural Sleeve 2?

The Neural Sleeve 2 is a second-generation wearable device engineered to re-educate muscles and improve mobility for individuals affected by conditions like multiple sclerosis, cerebral palsy, spinal cord injuries, and strokes. Through its AI-powered MultiStim technology, it enables the simultaneous activation of muscle movement and relaxation of spasms, which are often debilitating for individuals looking to regain mobility.

The announcement of its FDA clearance was celebrated by Cionic’s founder and CEO, Jeremiah Robison, who stated, “Spasticity is one of the most persistent barriers to mobility, yet it has been neglected for too long.” Cionic aims to break this cycle with their innovative device that tackles not only the immediate mobility impairments but also addresses broader issues associated with muscle spasms and rigidity.

Design and Features

Crafted in collaboration with the acclaimed design firm fuseproject, the Neural Sleeve 2 boasts a sleek, bionic-clothing-inspired aesthetic that promotes comfortable all-day wear. Enhancements in flexibility and sizing ensure that a larger demographic can benefit from its innovative technology. Users can expect not only functionality but also confidence as they don the sleeve while navigating their day-to-day activities.

Moreover, the device pairs seamlessly with the Cionic mobile app, offering users tailored guidance and support from expert mobility specialists. This holistic approach enhances the user experience, making it a comprehensive solution for regaining independent mobility.

Real-World Impact

Remarkably, over the past three years, since the first Neural Sleeve was launched in 2023, Cionic has demonstrated impressive outcomes. Their devices collectively amassed over 2 million hours of real-world use, stimulating nearly 500 million steps. In various trials, participants reported significant improvements in gait—showcasing a 94% success rate in post-test evaluations.

Data reveals astounding statistics, such as a 68% increase in foot clearance and a 44% enhancement in ankle stability. For many users, these improvements translate directly into a better quality of life, allowing them to partake in activities long thought impossible.

Collaborative Efforts

Cionic’s advancements are supported by partnerships with key organizations and clinical institutions like the National Multiple Sclerosis Society and Stanford University. This collaborative approach ensures robust feedback and insights are incorporated into the sleeve’s design, ultimately benefiting users and enhancing clinical efficacy.

Dr. Barry Singer, Director of the MS Center for Innovations in Care, summed up the device's revolutionary potential by stating, “It’s been remarkable. My patients using the Neural Sleeve can stay active and accomplish more throughout the day.” The continuous feedback from users and clinicians has been pivotal in guiding Cionic's innovations.

Future Directions

The launch of the Neural Sleeve 2 marks a new chapter in the quest for advanced mobility solutions. As Cionic continues to innovate, the overarching goal remains clear: to empower individuals with neurological conditions, promoting independence, and fostering a more active lifestyle. Robison summarizes the mission by stating that “Mobility is fundamental to independence,” and with devices like the Neural Sleeve 2, Cionic is poised to reshape the future of mobility care.

For individuals and families affected by neurological conditions, the Neural Sleeve 2 promises not just improved mobility but also a renewed sense of hope and freedom in navigating their lives. As research continues to evolve, all eyes are keenly focused on Cionic and their journey to redefine mobility care.

For additional details and future updates, visit Cionic's official website.