FDA Grants Breakthrough Device Designation To JelikaLite For Cognilum Wearable Device To Reduce Autism Symptoms In Children Ages 2 To 6

JelikaLite Corp., a medical technology company, announced that the U.S. Food and Drug Administration (FDA) has granted the Breakthrough Device Designation to its Cognilum™ System for the reduction of symptoms of moderate to severe autism spectrum disorder in children ages two to six. The Cognilum System is a data-device integrated system with wearable medical device that combines non-invasive brain stimulation with near-infrared light, EEG sensors, and  an artificial intelligence personalization platform. The system provides feedback for parents, caregivers, and primary care professionals.

The FDA designation is based on the outcomes of a double-blind, placebo controlled . . .