FDA Approves Leg Wearable for Neurological Conditions

The FDA has approved a novel wearable for commercial rollout – the Neural Sleeve. 

Fitted with electrodes to stimulate the wearer’s muscles (a method known as functional electrical stimulation), the new design has applications in patients suffering from neurological conditions such as cerebral palsy and multiple sclerosis, as well as those who have suffered a stroke or damage to their spinal cords.

Developed by bionic wearables designer Cionic, the Neural Sleeve uses artificial intelligence (AI) for real-time motion analysis. Monitoring a wearer’s gait, this data is used to inform the electrodes in each leg and adapt the stimulation accordingly. The user will be able to access this data on their phones, and can adjust the electrodes’ mode if they are sitting down or resting. 

The wearable is intended as a recovery aid, used to retrain a user’s movements and ultimately not be needed once a wearer has rebuilt a level of motion in a muscle. 

In a blog post, Cionic said its goal was “to create the world’s most advanced mobility solution … our technology was designed to address the underlying neuromuscular system with the goal to retrain and strengthen the body over time.”

The device is expected to be ready for delivery by 2023.