News Report | June 23, 2021
FDA Authorizes Marketing Of Cognoa’s Canvas Dx Autism Diagnostic Aid
On June 2, 2021, the U.S. Food and Drug Administration granted Cognoa marketing authorization for its Canvas Dx device to help diagnose autism. Canvas Dx is a machine learning-based software intended to help health care professionals diagnose autism in children 18 months through 5 years of age who at risk for developmental delay based on concerns of a parent, caregiver, or health care professional. CanvasDx is intended for use by primary care providers trained and qualified to interpret the results of a behavioral assessment examination and to diagnose autism. Health care professionals do not require any special training . . .