The startup Cognoa has submitted its app-based tool for FDA clearance

By Megan Scudellari

This week, a California-based company announced it will seek FDA clearance for a first-of-its-kind autism spectrum disorder (ASD) diagnostic tool. Cognoa’s technology uses artificial intelligence to make an ASD diagnosis within weeks of signs of concern—far faster than the current standard of care. If cleared by the FDA, it would be the first tool enabling primary care pediatricians to diagnose autism.

The approach is “innovative,” says Robin Goin-Kochel, a clinical autism researcher at Baylor College of Medicine and associate director for research at Texas Children’s Hospital’s Autism Center, who is not affiliated with Cognoa. The field absolutely needs a way to “minimize the time between first concerns about development or behavior and eventual ASD diagnosis,” she adds.

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