FDA authorizes Cognoa autism spectrum disorder diagnostic aid

U.S. FDA today authorized Cognoa’s machine learning-based software to help diagnose autism spectrum disorder.

The de novo authorization from FDA covers the use of the Cognoa ASD Diagnosis Aid with children 18 months through 5 years of age with potential ASD symptoms. Palo Alto, Calif.–based Cognoa has touted the software as a way to do away with the time delays parents can experience as they try to schedule their children with specialists after a referral from a pediatrician.

“Autism spectrum disorder can delay a child’s physical, cognitive and social development, including motor skill development, learning, communication and interacting with others. The earlier ASD can be diagnosed, the more quickly intervention strategies and appropriate therapies can begin,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a news release.

The Cognoa ASD Diagnosis Aid uses a machine-learning algorithm to receive input fro…

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