FDA Authorizes Marketing Of Diagnostic Aid For Autism Spectrum Disorder

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

The Centers for Disease Control and Prevention (CDC) 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. Because ASD . . .