FDA Grants De Novo Clearance to AI-Based Autism Diagnosis Aid


The device is designed to assist in diagnosis to provide early intervention and appropriate care.

The US Food and Drug Administration (FDA) has granted de novo clearance for an AI-based, diagnostic aid (Canvas Dx) designed to aid physicians in primary care diagnosis of autism.

The clearance, granted to Cognoa, is the first authorized to aid in primary care diagnosis of autism in young children, with the goal of shortening time-to-diagnosis and initiation of earlier interventions.

It is indicated for use in diagnosis of autism spectrum disorder for patients aged 18 – 72 months at risk of developmental delay, based on concerns from parent, caregiver, or healthcare provider.

Data show while early diagnosis has greater potential to improve lifelong outcomes, non-white children, females, and those from disadvantaged socioeconomic backgrounds are often diagnosed later or left undiagnosed.

The Device

The AI-based autism diagnosis aid evaluates caregiver information completed at home via an app and physician input.

If there is sufficient information available, the device will generate a result to use as an aid to diagnose or rule out autism and appropriate next steps in care.

The device is designed to facilitate diagnosis in weeks, compared to the standard month or years for families to access early intervention and appropriate care earlier.

Further, the AI algorithm is trained to use diverse datasets in race, gender, educational level, and socioeconomic status, helping physicians avoid bias and disparities in the current diagnostic process.

The clearance followed a double-blinded, cohort study of 425 participants aged 18 – 72 months which exceeded endpoints. The device was granted Breakthrough Device Designation by the FDA in October 2018.


Dave Happel, CEO of Cognoa said in a statement the current system is at a breaking point in early intervention and rapidly rising autism rates will worsen without new approaches to autism diagnosis.

“The FDA authorization of our diagnosis aid, Canvas Dx, is a significant milestone in Cognoa's development and a crucial step towards making early diagnoses more accessible to children and families - regardless of gender, ethnicity, race, zip code, or socio-economic background,” Happel said.

Colleen Kraft, MD, Senior Medical Director of Clinical Adoption at Cognoa, followed up stating that the device will provide better neurodevelopment information and allow pediatricians to respond to early developmental concerns

“Many are already managing children with behavioral health conditions such as ADHD, anxiety, and depression,” Kraft said. “Canvas Dx will provide primary care physicians actionable information to better understand their patients' neurodevelopmental picture, allowing pediatricians, who are frequently the primary point of contact for families, to respond to early developmental concerns."

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