Cionic announced today that it received FDA clearance for its leg-worn Cionic Neural Sleeve that provides functional electrical stimulation.
San Francisco-based Cionic designed its lightweight Cionic Neural Sleeve to assist in gait for people with foot drop and leg muscle weakness, including those with mobility issues due to multiple sclerosis (MS), stroke, cerebral palsy (CP) and other neurological conditions.
In a news release, Cionic said its Cionic Neural Sleeve is the first product to combine movement analysis and augmentation into a wearable garment.
The Cionic Neural Sleeve analyzes, predicts and augments a person’s movement through the use of advanced algorithms, reading the signal sent from the brain to the muscles and predicting a person’s movement 1/10th of a second before their foot lifts off the ground.
“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,” Cionic Founder and CEO Jeremiah Robison said in the release. “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.”
The company said it plans to bring the Cionic Neural Sleeve to market later this year.