The Food and Drug Administration (FDA) has authorized marketing of the Cognoa ASD Diagnosis Aid, an AI-driven device that facilitates the diagnosis of autism spectrum disorder (ASD).

The Cognoa ASD Diagnosis Aid is a machine learning-based software intended to help diagnose ASD in patients 18 months through 5 years of age who exhibit potential symptoms of the disorder and are at risk of developmental delay. The device is not indicated for use as a stand-alone diagnostic device but as an adjunct to the diagnostic process.

The diagnostic aid includes a mobile app for caregivers and patients to answer questions and upload videos of their child; a video analysis portal that allows manufacturer-trained and certified specialists to view and analyze uploaded videos; and a health care provider portal to track information and review results. Once sufficient information is gathered from parents, caregivers, and health care providers through questionnaires and uploaded videos, the tool will report a positive or negative diagnosis for ASD. If there is insufficient information to determine a diagnosis, the device will report that no result can be generated.

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The approval of the Cognoa ASD Diagnosis Aid was based on safety and efficacy data from a study that included 425 patients 18 months through 5 years of age (median age, 2.8 years). The assessments made by the device were compared with a panel of clinical experts who used the current standard ASD diagnostic process.

Results showed that the device diagnosed 32% of patients as positive or negative for ASD, which matched the panel’s conclusions for 81% of patients who tested positive and 98% of patients who tested negative. The device also made an accurate ASD determination in 98.4% of patients with the condition and in 78.9% of patients without the condition.

The Cognoa ASD Diagnosis Aid will be marketed under the name, Canvas DxTM, and is expected to be made available later in 2021.

“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,” commented Dr Colleen Kraft, former president of the American Academy of Pediatrics and current senior medical director of Clinical Adoption at Cognoa.


  1. FDA authorizes marketing of diagnostic aid for autism spectrum disorder. [press release]. Silver Spring, MD: US Food and Drug Administration; June 2, 2021. 
  2. Cognoa receives FDA marketing authorization for first-of-its-kind autism diagnosis aid. [press release]. Palo Alto, CA: Cognoa; June 2, 2021.

This article originally appeared on MPR