FDA Designates Cognoa’s Software as a Class II Diagnostic Device

The FDA determined that Cognoa’s AI-based software for pediatric behavioral health diagnostics is a Class II medical device. 

Based on technology originally developed at Harvard and Stanford’s medical schools, Cognoa’s machine learning platform determines the most predictive data to identify risks for behavioral delays and support a diagnosis of autism based upon the child’s natural behavior at home.

The company plans to offer additional precision medicine applications for faster behavioral health diagnostics.