FDA Green Lights Cognoa’s Autism Diagnostic Device

As the health care system currently operates, it can take months or even years for children on the autism spectrum to get a diagnosis and begin applied behavioral analysis (ABA) therapy.

Oftentimes, pediatricians are the first clinicians to see those children; however, few feel comfortable making the diagnosis themselves, instead referring children to autism specialists, who are in short supply with long wait lists.

A new first-of-its-kind autism screening tool aims to change that, and it just received the regulatory green light to be used in the U.S.


Cognoa, which creates diagnostic and therapeutic aids for children with behavioral health conditions, has received approval from the U.S. Food and Drug Administration (FDA) to market a device to physicians for diagnosing autism in the primary care setting.

Palo Alto, California-based Cognoa announced the approval of Canvas Dx Wednesday. The solution is also the first autism diagnosis aid approved by the FDA for commercialization.

Canvas Dx uses artificial intelligence (AI) to evaluate information about a child’s behavioral condition to help determine if said child is at risk for a developmental delay. That information comes from caregivers and physicians, who enter their observations into an app.

The solution then uses those inputs to generate a result, which the physician uses to determine whether the child has autism and direct them to the most appropriate next site of care. The device is available by prescription.


The goal of Canvas Dx, according to the company’s press release, is to speed up the process of treating children with autism. Currently, one and 54 children in the United States have been diagnosed with ASD, an increase of 178% since 2000.

The device is intended for use as a supplemental tool for children ages 18 to 72 months — whereas for decades, the average age of autism diagnosis has been four to five years old. The diagnosis delay — which can adversely affect children’s neurological development — has particularly affected those who are non-white and female, as well as rural residents and those of lower socioeconomic backgrounds.

The company has been bullish about Canvas Dx’s potential since it was granted a Breakthrough Device Designation by the FDA in October 2018 — and since a study of the tool proved to generate positive results.

“Cognoa’s AI is able to reference troves of external data points and utilize the combined experiences of thousands of physicians, simultaneously assessing many features of a child while analyzing them for predictive autism signals – something a physician (or any human) is simply unable to do,” Cognoa CEO Dave Happel told Behavioral Health Business earlier this year. “Cognoa’s AI works by analyzing a combination of inputs including: videos of children in natural settings, a parental questionnaire and a health care provider questionnaire.”

In its press release announcing the FDA approval, Happel said Canvas Dx will be instrumental in making prompt autism diagnoses available and equitable for all children.

“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,” Happel said in the press release. “With rapidly-rising autism rates, this crisis will only worsen without new approaches and innovations. The FDA authorization of our diagnosis aid … 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.”

Since its founding in 2013, Cognoa has raised almost $54 million according to fundraising tracking site Crunchbase. Its previous investors include Morningside Group and the Stanford Technology Ventures Program, an entrepreneurial accelerator of the School of Engineering at Stanford University.

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