FDA Authorizes Marketing Of Cognoa ASD Diagnostic Aid For Autism Spectrum Disorder

The U.S. Food and Drug Administration (FDA) granted marketing authorization to Cognoa, Inc. for 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 professionals diagnose ASD in children 18 months through 5 years of age who exhibit potential symptoms of the disorder.

The Cognoa ASD Diagnosis Aid uses input from parents or caregivers, video analysts and health care providers to help physicians evaluate a child's risk of ASD. The device consists of three main components:

A mobile app for caregivers and parents . . .