JelikaLite’s Cognium Device for Autism Gains Breakthrough Designation

JelikaLite’s Cognilum system for treatment of autism symptoms has been designated a breakthrough device by the FDA.

The system, which combines noninvasive brain stimulation with near-infrared light, EEG sensors and an artificial intelligence-based personalization platform, is intended to reduce symptoms of moderate-to-severe autism spectrum disorder in pediatric patients age two to six.

The designation was based on the results of a clinical trial of 30 pediatric patients with moderate-to-severe autism, in which Cognilum demonstrated improvements in communication and daily living skills.