FDA OKs Cionic’s Neural Sleeve

“Bionic clothing” maker Cionic has been granted U.S. Food and Drug Administration (FDA) clearance for its first product, the Cionic Neural Sleeve, for functional electrical stimulation to assist in gait for those with foot drop and leg muscle weakness.
 
The Neural Sleeve can help people with mobility issues due to multiple sclerosis, cerebral palsy, and other neurological conditions.
 
“We are incredibly excited for the Cionic Neural Sleeve to be an FDA cleared Class II medical device and are ready to start impacting the lives of individuals with movement challenges in meaningful ways,” Jeremiah Robison, founder and CEO of Cionic told the press. “Our mission is to become the new standard of care by addressing the underlying brain body connections, enabling confident movement, and greater engagement in the community.”
 
“This would not have been possible without the more than 70 individuals across multiple sclerosis, stroke, cerebral palsy, and spinal cord injury who participated in our trials. Together with our research partners at Cleveland State University we were able to demonstrate statistically significant improvement to foot clearance, leading to more stable and confident walking,” continued Robison.
 
Jim Vecchi, who has been participating in Cionic’s multiple sclerosis trials, described his experience with the Neural Sleeve.
 
“Wearing the Neural Sleeve, I move in a way that is more flowing and natural. I am walking more quickly and smoothly, while using less energy in doing so. Already I feel that I am getting stronger and more endurant,” said Vecchi. “I should also mention that the Neural Sleeve is surprisingly comfortable and my body has become accustomed to wearing it surprisingly quickly. I do not have the words to properly explain the positive effects on my confidence and outlook. I very much look forward to seeing what progress I can make with the help of the Neural Sleeve.”
 
Cionic was founded in 2018, motivated by Robison’s daughter’s mobility journey after her cerebral palsy diagnosis.