Cognoa Receives FDA Marketing Authorization For First-Of-Its-Kind Autism Diagnosis Aid

Cognoa, a pediatric behavioral health company developing diagnostic and therapeutic solutions for children living with behavioral health conditions, announced that the U.S. Food and Drug Administration (FDA) has granted the company’s De Novo classification request for its autism diagnosis aid, Canvas Dx. The AI-based device is the first FDA-authorized diagnosis aid designed to help primary care professionals diagnose autism in the primary care setting.

Canvas Dx is an artificial intelligence (AI)-based diagnosis aid designed to equip primary care primary care professionals to accurately and efficiently diagnose autism in children at risk for developmental delay. Canvas . . .