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Cognoa Receives FDA Marketing Authorization for First-of-its-kind Autism Diagnosis Aid

Cognoa’s AI-driven device is the first FDA-authorized diagnosis aid designed to help primary care physicians diagnose autism in young children with the goal of shortening time-to-diagnosis and enabling initiation of earlier interventions

(Palo Alto, Calif. – June 2nd, 2021) Cognoa, a pediatric behavioral health company developing diagnostic and therapeutic solutions for children living with behavioral health conditions, today announced that the U.S. Food and Drug Administration (FDA) has granted the company’s De Novo classification request for its autism diagnosis aid. The AI-based device is the first FDA-authorized diagnosis aid designed to help physicians to diagnose autism in the primary care setting.

Autism is an increasingly common neurodevelopmental condition that today affects one in every 54 children in the United States, a 178% increase in prevalence since 2000. While autism can be reliably diagnosed in children as early as 18 months, the average age of autism diagnosis has remained at 4 to 5 years old for decades. Non-white children, females, and those from rural areas or disadvantaged socio-economic backgrounds are often diagnosed even later, or missed altogether. This reality means many children miss a critical neurodevelopmental window when early diagnosis and subsequent early interventions have the greatest potential to improve lifelong outcomes. Disparities in autism diagnosis are largely due to the lack of female and diverse representation in autism research to date. In addition, the reliance on diagnostic assessments that are time-consuming to administer within the specialty care setting and the growing shortage of diagnostic specialists contribute to the average three year delay between first concern and diagnosis.

“The current system is already at a breaking point as it is unable to provide early diagnoses and intervention opportunities to many children and families. With rapidly-rising autism rates, this crisis will only worsen without new approaches and innovations,” said Dave Happel, CEO of Cognoa. “The FDA authorization of our diagnosis aid, Canvas DxTM, 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. We look forward to partnering with the healthcare community as we introduce Canvas Dx in the coming months.”

“Primary care physicians are uniquely positioned to identify developmental delay and behavioral conditions. Many are already managing children with behavioral health conditions such as ADHD, anxiety, and depression,” said Dr. Colleen Kraft, former American Academy of Pediatrics President and current Senior Medical Director of Clinical Adoption at Cognoa. “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.”

About Canvas Dx

Canvas Dx is an AI-based diagnosis aid designed to equip primary care physicians to accurately and efficiently diagnose autism in children at risk for developmental delay. Canvas Dx evaluates both caregiver information completed at home via an app and physician inputs, and if the information is sufficient, generates a result that the physician uses as an aid to diagnose or rule out autism and direct appropriate next-steps-in-care. From the time of parental or physician initial concern to diagnosis, Canvas Dx is designed to help facilitate a diagnosis in a few weeks – not months or years, as is standard in today’s diagnostic processes – so that children and families can access early interventions and appropriate care sooner. With its AI algorithm trained using diverse datasets in terms of race, gender, educational level, and socioeconomic status, Canvas Dx has the potential to help primary care physicians avoid biases and disparities existing in the current autism diagnostic process. The FDA marketing authorization has been granted following a successful pivotal study in which the device exceeded study endpoints. To stay updated, visit

Canvas Dx Indication for Use

Canvas Dx is intended for use by healthcare providers as an aid in the diagnosis of autism spectrum disorder (ASD) for patients ages 18 months through 72 months who are at risk for developmental delay based on concerns of a parent, caregiver, or healthcare provider. The device is not intended for use as a stand-alone diagnostic device but as an adjunct to the diagnostic process. The device is for prescription use only.

About Cognoa

Cognoa is a pediatric behavioral health company developing diagnostic and therapeutic solutions with the goals of enabling equitable access to care and improving the lives and outcomes of children and families living with behavioral conditions, starting with autism. Cognoa’s products are intended to be routinely prescribed by providers and covered by insurers. For more information, visit