FDA Approves Device to Diagnose Autism

Cognoa ASD Diagnosis Aid approved to help doctors diagnose autism in kids

(RxWiki News) The US Food and Drug Administration (FDA) has approved a new device to help health care providers diagnose autism in children.

This new device, called the Cognoa ASD Diagnosis Aid, is a machine-learning software that uses an algorithm to analyze information from patients and caregivers to inform a possible autism diagnosis. The FDA approved it for use with children between the ages of 18 months and 5 years old.

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

The Cognoa ASD Diagnosis Aid helps caregivers diagnose autism through three main channels:

  • A mobile app that allows parents and caregivers to answer questions and upload videos of the child
  • A video-analysis portal that allows trained experts to see and analyze videos of the patient
  • A portal for health care providers to track progress, view reports and answer questions from parents

The FDA noted that this new device is not meant to diagnose autism on its own. Instead, it is meant to aid in the normal autism assessment and diagnosis processes.

A study of 425 children between 18 months and 5 years old found that the Cognoa ASD Diagnosis Aid was generally accurate in its assessment. Both the device and a panel of experts assessed the children in the study. In children who were diagnosed with autism, the device matched the panel's assessment 81 percent of the time. For children who were negative for autism, the device and the panel agreed 98 percent of the time.

The primary risk tied to this device is possible misdiagnosis, the FDA noted. A wrong or delayed diagnosis can lead to delayed or inappropriate treatment.

The FDA approved the marketing of this device for Cognoa, Inc.

If you are concerned about your child's development, speak with your pediatrician or family doctor.

Review Date: 
June 6, 2021