FDA authorizes new device to help diagnose pediatric autism

The US Food and Drug Administration on 2 June authorized the marketing of a first-of-its kind device intended to help diagnose autism spectrum disorder (ASD) in children aged 18 months through 5 years.

The device was developed by Cognoa, a company based in Palo Alto, CA, that develops diagnostic devices for the pediatric population. The company submitted its application, for the de novo pathway for new types of low-to-moderate-risk devices in September 2020.