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Start-Up Spotlight: Cognoa Seeks Breakthrough In Early Diagnosis Of Autism And ADD

Executive Summary

US FDA recently granted Cognoa’s autism diagnostic device a Breakthrough Device designation to accelerate its efforts to get the first FDA-cleared medical device for the early diagnosis of autistic spectrum disorder (ASD) to market. The average age of ASD diagnosis is about four years old, but extensive clinical research has shown that earlier diagnosis of ASD can improve outcomes over the child’s lifetime. Cognoa’s system is intended to allow primary care physicians to diagnosis ASD in the children as young as 18 months.

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