FDA Authorizes New Device to Help Diagnose Pediatric Autism

Posted 02 June 2021 | By Joanne S. Eglovitch 

The US Food and Drug Administration on 2 June authorized the marketing of a first-of-its kind device intended to help diagnose autism spectrum disorder (ASD) in children aged 18 months through 5 years.

The device was developed by Cognoa, a company based in Palo Alto, CA, that develops diagnostic devices for the pediatric population. The company submitted its application, for the de novo pathway for new types of low-to-moderate-risk devices in September 2020.

“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 Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a press release announcing the Cognoa authorization. “Today’s marketing authorization provides a new tool for helping diagnose children with ASD.”

The FDA’s favorable decision for the Cognoa ASD Diagnosis Aid was based on safety and effectiveness findings from a 14-site study of 425 patients aged 18 months through 5 years. The study compared the assessments made by the device against the assessments made by a panel of clinical experts who used current standard ASD diagnostic process. The device’s analysis and the conclusions of the panel concurred in 81% of patients testing positive and 98% of patients testing negative for ASD.

The Cognoa ASD diagnosis aid is a machine learning-based software system that receives input from parents or caregivers and healthcare providers, and consists of three main components: a mobile app that allows parents and caregivers to respond to questions about the patient’s behavior problems and allows them to upload videos; a video analysis portal that allows the uploaded videos to be analyzed by certified specialists trained by the manufacturer; and a portal for health care providers to respond to pre-loaded questions about behavior problems.

After processing information taken in through the three portals, the ASD diagnosis aid reports a positive or negative result to aid in diagnosis of ASD, or reports that insufficient information has been provided to generate a positive or negative result. The device cannot generate a diagnosis of autism; it is meant to be used as a diagnostic aid.

The authorization establishes special controls for devices of this type, including requirements related to labeling and performance testing. The special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type.

Now that the Cognoa device has received its authorization through the de novo premarket pathway, subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process.

In the press release, FDA noted that both misdiagnosis and delayed diagnosis of ASD are risks associated with the Cognoa ASD diagnosis aid.  “Both misdiagnosis or missed diagnosis can result in delayed treatment of ASD and delivery of treatment not appropriate for ASD,” wrote the agency.