Cognoa has secured breakthrough designations from the US Food and Drug Administration’s (FDA) for its digital diagnostic and digital therapeutic devices for autism.


Image: FDA’s Center for Devices and Radiological Health in Silver Spring, Maryland. Photo: Courtesy of The U.S. Food and Drug Administration/

Cognoa stated that the products are the foundation for the company’s precision health platform designed to support early identification and treatment of pediatric behavioral health conditions.

The companys digital precision health platform uses machine learning and predictive analytics to inputs from parents and diagnostic data and responses to therapeutics to create more personalized care.

By integrating diagnostics and therapeutics into a single platform, clinicians can arrive at accurate diagnostic and therapeutic decisions faster and modify the treatments in more informed ways.

The company claims that its therapeutic developments leverage five years of work in diagnostics data science and machine learning in the behavioral health domain.

The FDA breakthrough device program could help patients receive timely access to breakthrough technologies that can offer an effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.

Under this program, the FDA will offer Cognoa, priority review and interactive communication on device development and clinical trial protocols, through to commercialization decisions.

Cognoa CEO and co-founder Brent Vaughan said: “The greatest opportunity within behavioral health is helping children. 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 company’s digital precision health platform includes ASD Diagnostic Device and ASD Therapeutic Device.

Cognoa’s ASD diagnostic device in development is touted to have been designed to support healthcare professionals in rendering diagnosis of ASD in children ages 18-72 months who are at risk for developmental delays.

The ASD Therapeutic Device can help improve socialization in children with ASD and claims to addresses a core deficit of autism. Cognoa’s first digital therapeutic device is designed to improve social skills and responsiveness of children with ASD.

The device is intended for use in outside of clinician’s office to supplement existing therapies and give patients timely access to care. It can also reduce waiting lists and meet the needs of an increasing population.