The US Food and Drug Administration has authorized first-of-its-kind breakthrough medical software that could help diagnose children with autism spectrum disorder (ASD) early and get them therapy sooner. The software uses machine learning, and a combination of apps and specialists working remotely to give an initial assessment whether a child has ASD before being referred to a specialist.
Cognoa submitted a de novo application for its Canvas Dx in September 2020 and was granted marketing authorization on 2 June. The software as a medical device (SaMD) is now...