Cognoa, a digital health company focused on behavioral health for children, today announced FDA Breakthrough designations for it’s first diagnostic and therapeutic devices to identify and treat autism. This is the foundation for its AI-based digital precision health to support the developmental and behavioral health of children, combining diagnostics and therapeutics into one platform. This signifies a big step in the company’s expansion into therapeutics.
FDA Breakthrough Devices Program Overview
The Breakthrough Devices Program is intended to expedite development and review of certain medical devices that have the potential to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions and diseases. 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.
Today, most children in the US receive an autism diagnosis, and subsequent treatments, after the age when interventions have the greatest opportunity to impact the lifetime trajectory of a child. Cognoa’s goal is to empower parents and their pediatricians in ways that enable earlier and more targeted interventions and life-changing results for kids and their families. Cognoa currently provides the Cognoa Child Development app via partnerships with employers, payers, and ABA therapy centers to empower parents and caregivers to better support their children’s unique behavioral health and growth.
Cognoa’s Digital Precision Health Platform
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.
Autism Diagnostic and Digital Therapeutic Devices
– Cognoa’s ASD Diagnostic Device in development is designed to help healthcare professionals render a diagnosis of ASD in children ages 18-72 months who are at risk for developmental delays.
– Cognoa’s first digital therapeutic device is designed to improve social skills and responsiveness of children with ASD. It is intended for use outside of the clinician’s office to supplement existing therapies and give patients timely and convenient access to care, with the potential to reduce waitlists and meet the needs of an increasing population.
“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.”