FDA approves the Cognoa ASD Diagnosis Aid for autism!


Federal regulators authorized a device to help primary care doctors determine whether or not a child has autism. This will allow kids to be diagnosed far sooner, and they will not have to wait long for specialists. The green signal to market the Cognoa ASD Diagnosis Aid was given by the Food and Drug Administration this month, branded Canvas Dx.

An algorithm to analyze data is used by the machine learning-based software submitted by health care providers and parents to return a positive or negative for ASD response for a child. To use the device, caregivers and parents answer questions about behavior and, through a mobile app, submit videos of a child. Through a special portal, the healthcare workers answer questions. Certified specialists review the videos, and the algorithm decides only if sufficient information is provided.


According to Cognoa, it is the first device authorized by the FDA to help primary care physicians diagnose autism which makes the product. The condition of autism could be challenging to diagnose because symptoms vary, the FDA said. As a result, the latest data from CDC shows that the median age for autism diagnosis is older than four even though the developmental disability can be reliably detected by age 2.

The families’ main problem is long waits to see a clinician skilled in evaluating children for autism. The Cognoa aid will solve this problem with less specialized training the tools given to primary care physicians to make a diagnosis themselves. Within a few weeks, that can happen with the device, according to the company.

“Autism spectrum disorder can delay a child’s physical, cognitive and social development, including motor skill development, learning, communication and interacting with others. The earlier ASD can be diagnosed, the more quickly intervention strategies and appropriate therapies can begin,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “Today’s marketing authorization provides a new tool for helping diagnose children with ASD.”