FDA Approves Cognoa’s Autism Diagnosis Device

Cognoa has received FDA De Novo authorization for Canvas Dx, an artificial intelligence-powered device used to help in the diagnosis of autism.

The device, the first authorized for diagnosing autism in the primary care setting, is designed to assist primary healthcare providers in the diagnosis of autism in children at risk of developmental delay.

Canvas Dx assesses information completed at home by caregivers, using an app as well as inputs from physicians to diagnose or rule out autism. In the case of a positive diagnosis, the device will suggest appropriate next steps for care.