The U.S Food and Drug Administration (FDA) authorized the marketing of unique autism diagnostic device developed by Cognoa to help diagnose autism spectrum disorder (ASD) in young children between 18 months and 5 years of age. Using a machine learning- based software system, Cognoa’s ASD diagnosis aid device consists of three main components: a mobile app, a video analysis portal, and a portal tailored to healthcare providers. Its aim is to combat delayed diagnoses and treatment of ASD in minors. The FDA based its decision on a 14-site study which included 425 patients, aged 18 months to 5 years, and compared the assessments made by the device against those made by a panel of clinical experts. Findings from the device’s analysis and from the experts’ assessments matched, concurring that 81% of patients had a positive test result, and 98% of patients tested negative for ASD.
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