Cognoa Hits Major Milestone Towards First AI-Based Autism Diagnostic

Following FDA determination that Cognoa’s software is a Class II diagnostic medical device, Cognoa has a clear path to fundamentally change the way patients are diagnosed and treated for behavioral health conditions

PALO ALTO, Calif., Feb. 21, 2018 (GLOBE NEWSWIRE) -- Cognoa, a company offering an AI-based platform for pediatric behavioral health diagnostics and digital therapeutics, announces that the U.S. Food and Drug Administration (FDA) has established that Cognoa’s software is a Class II diagnostic medical device for autism. This milestone will expand Cognoa’s ability to offer its solution to enterprise customers, healthcare payers, and directly to clinicians in primary care settings.

Cognoa’s AI-based platform assists physicians to improve the timeliness and scale of the diagnosis and treatment of behavioral health conditions. In today’s healthcare system, the average age of autism diagnosis is 4.1 years, which falls after the critical early intervention window when therapy has its greatest impact. Cognoa’s first application has been clinically validated to identify autism in children as early as 18 months of age.

For enterprise companies and healthcare payers, Cognoa provides an opportunity to offer healthcare benefits that create life-long gains for children, while reducing costs associated with the treatment of behavioral health. For clinicians, Cognoa enables diagnosis with greater, faster precision, within the critical early intervention time frame.

“Today, there is a profound, unmet need for earlier and more accurate diagnoses of behavioral health conditions which we know can create life-changing results for children and their families,” said Brent Vaughan, CEO of Cognoa. “We are very encouraged by this FDA determination of Cognoa’s AI-based software as a medical device for diagnosis. Cognoa is committed to conducting additional clinical studies and working with both the FDA and clinicians to further validate both our diagnostic software as well as integrated digital therapeutics that will dramatically improve the standard of care for physicians, children and their families.”

Based on AI 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 based upon the child’s natural behavior at home. Using data from the diagnosis, the application recommends personalized, evidence-based activities such as behavioral interventions parents can do at home to best support their child’s development.

“For years, primary care physicians have been referring children with suspected behavioral and developmental conditions for more extensive evaluations for autism spectrum disorders. This results in a logjam of children, with varying levels of severity, waiting for these assessments,” said Dr. Daniel Coury, Professor of Pediatrics and Psychiatry at Nationwide Children's Hospital and The Ohio State University, and Medical Director of the Autism Speaks Autism Treatment Network. “Cognoa has completed several well-designed clinical trials and has engaged early with the FDA. What’s exciting is how Cognoa will be able to empower primary care physicians to make a primary diagnosis and refer children directly for treatment, greatly reducing the time from diagnosis to meaningful interventions and leading to better outcomes.”

About Cognoa
Cognoa develops AI-based digital diagnostics and personalized therapeutics that provide accurate, earlier diagnoses and more effective treatments to improve outcomes and lower behavioral healthcare costs. Its first clinically-validated mobile application identifies autism as early as 18 months of age, when early intervention has the greatest potential for improved lifelong outcomes, over two and half years sooner than the national average age of 4.1 years. Cognoa provides its applications to parents through their employers and benefit providers and has been used by over 250,000 families. Cognoa is working with clinicians to offer additional precision medicine applications for faster behavioral health diagnostics and more personalized therapeutics, enabling greater opportunities for life-changing outcomes. For more information, visit

Media Contact
Courtney Calderon
Uproar PR for Cognoa