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FDA authorizes marketing of a device to help diagnose autism spectrum disorder

June 2, 2021

Today, the U.S. Food and Drug Administration authorized marketing of a device to help diagnose autism spectrum disorder (ASD). The Cognoa ASD Diagnosis Aid is a machine learning-based software intended to help health care providers diagnose ASD in children 18 months through 5 years of age who exhibit potential symptoms of the disorder.

The Centers for Disease Control and Prevention defines ASD as a “developmental disability that can cause significant social, communication and behavioral challenges” and is estimated to affect about 1 in 54 children.

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