Cognoa, a digital devices maker, has obtained the US Food and Drug Administration (FDA) breakthrough device designation for its diagnostic and therapeutic devices intended for autism spectrum disorder (ASD).
The devices are based on the company’s digital precision health platform and have been designed to enable the early detection and treatment of the behavioural health condition in children.
The Cognoa platform leverages machine learning and predictive analytics. The technology is applied to parental inputs, diagnostic data and responses to therapeutics in order to deliver personalised care.
The company believes that a combination of diagnostics and therapeutics on a single platform will enable clinicians to make accurate diagnostic decisions and plan more informed treatments.
The Cognoa ASD Diagnostic Device is being developed to help diagnose autism ASD in children aged 18-72 months, who are at risk for developmental delays.
The average age of ASD diagnosis has remained at more than four years old, which is said to be after the brain plasticity window that is considered important to maximise treatment outcomes.
Cognoa ASD Therapeutic Device is a digital solution designed to improve social skills and responsiveness of children with autism. Improvements in socialisation are said to address a core deficit of autism.
The device is meant to be used outside the clinician’s office to support current therapies and provide timely access to care. It is claimed to have the potential to cut waiting lists and cater to the growing population.
Cognoa co-founder and CEO Brent Vaughan said: “We believe AI-based precision health can empower parents and their paediatricians 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 recognises 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.”
Under the breakthrough device programme, the FDA will offer priority review and interactive communication about development and clinical trial protocols, through to commercialisation decisions.