FDA greenlights Cognoa's tool to detect autism spectrum disorder in kids

Pediatric behavioral health company Cognoa has received FDA De Novo classification for its autism spectrum disorder (ASD) software diagnostic aid, Canvas Dx. The ASD diagnostic tool is designed to help primary care clinicians and pediatricians evaluate and diagnose suspected cases of autism among children. It uses machine learning algorithms to analyze videos of the child's behavior and responses to questions uploaded by parents and caregivers to devise a diagnosis. Canvas Dx is indicated as an aid in the diagnosis of ASD in patients between the ages 18 months and 5 years old who are at risk of developmental delay based on concerns of a parent, caregiver or healthcare provider. It is not intended to be used as a standalone diagnostic device.