Cognoa’s Autism Diagnostic & Digital Therapeutic Devices Win FDA Breakthrough Status

Cognoa, a company at the forefront of digital behavioral health for children, announces it has received Breakthrough Device designations from the U.S. Food and Drug Administration (FDA) for its lead products, the first digital diagnostic and digital therapeutic devices for autism. These products are the foundation of Cognoa’s precision health platform designed to support earlier identification and treatment of pediatric behavioral health conditions. Today, most children in the US who receive an autism diagnosis, and subsequent treatments, do so after the age when interventions have the greatest opportunity to impact the lifetime trajectory of the child.
 
“The greatest opportunity within behavioral health is helping children,” said Brent Vaughan, CEO and co-founder of Cognoa Inc. “We believe AI-based precision health can empower parents and their pediatricians to act on early concerns that are highly predictive of developmental delays, like autism, with potentially life-changing results for children and their families. We are thankful that the FDA recognizes the critical need for innovative solutions to help address these challenges. We look forward to working closely with them to further our clinical studies and support our development.”
 
The FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide Cognoa with priority review and interactive communication regarding device development and clinical trial protocols, through to commercialization decisions.
 
“It hurts to see people suffer because they aren’t receiving timely help,” said Dr. Sharief Taraman, M.D., chief medical officer of Cognoa Inc. “Families experience long delays. Up to three years can pass from the time parents first express a concern and an autism diagnosis. This is precious time lost. Even when a diagnosis is received, the cost and availability of therapy can create further barriers to treatment. We are working towards a future where parents are more empowered to help their children progress, clinicians are better equipped and care is more cost-effective for payers.”
 
Cognoa’s digital precision health platform applies machine learning and predictive analytics to parental inputs and diagnostic data and responses to therapeutics to create more personalized care. By combining diagnostics and therapeutics into a single platform, clinicians will be empowered to come to accurate diagnostic and therapeutic decisions faster and modify treatments in more informed ways. The company’s therapeutic developments leverage five years of work in diagnostics data science and machine learning in the behavioral health domain.