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FDA Clears AI-Based Diagnostic Aid for Autism Spectrum Disorder


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The Food and Drug Administration (FDA) has authorized marketing of the Cognoa ASD Diagnosis Aid, an AI-driven device that facilitates the diagnosis of autism spectrum disorder (ASD).
The Cognoa ASD Diagnosis Aid is a machine learning-based software intended to help diagnose ASD in patients 18 months through 5 years of age who exhibit potential symptoms of the disorder and are at risk of developmental delay. The device is not indicated for use as a stand-alone diagnostic device but as an adjunct to the diagnostic process.
The diagnostic aid includes a mobile app for caregivers and patients to answer questions and upload videos of their child; a video analysis portal that allows manufacturer-trained and certified specialists to view and analyze uploaded videos; and a health care provider portal to track information and review results. Once sufficient information is gathered from parents, caregivers, and health care providers through questionnaires a ....

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