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Cognoa Seeks De Novo Clearance For AI-Powered Diagnostic App For Autism After Successful Study

 
• By Marion Webb

FDA clearance of the ASD Diagnostic app could lead to early diagnosis, improving quality of life of children with ASD and their caregivers. 

A colorful autism awareness puzzle background with wood texture illustration.

Cognoa is one step closer in its effort to get the first US Food and Drug Administration-cleared medical device for early diagnosis of autistic spectrum disorder (ASD) to market.

The Palo Alto, CA-based company announced on 23 September it will be submitting its artificial-intelligence-powered digital app for early detection of autism for de novo clearance. If cleared by the...

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