FDA Clears Tool To Help Diagnose Autism

Federal regulators are green-lighting a new tool designed to help clinicians identify children with autism.

The Food and Drug Administration cleared Neurora this month to inform decisions about diagnosing children ages 18 months to 12 years.

The device from Argus Cognitive, Inc. uses more than 100 biometrics to assess whether a child has autism.

Clinicians can upload video and audio from typical behavioral assessments to the Neurora portal. The tool measures facial expressions, voice patterns, eye gaze and more to evaluate how a child’s behavior compares to children with and without autism.

The results are intended to be considered in conjunction with “other findings and professional judgment,” Argus Cognitive said.

“We built Neurora to support clinicians evaluating children for autism,” said Dr. Attila Meretei, CEO and cofounder of Argus Cognitive. “Neurora works inside the assessment clinicians already use, without protocol changes or proprietary hardware, and is fully automated. Our goal is to reinforce every diagnosis with robust, quantitative evidence.”

Argus Cognitive said Neurora’s development was supported by a National Institutes of Health grant for entrepreneurs. A study published earlier this year found that the tool could distinguish between children with and without autism in nearly 78% of cases.

Neurora is one of a handful of devices now available to diagnosticians. The FDA previously cleared EarliPoint Evaluation for ASD, which uses eye-tracking technology to analyze visual behavior, as well as Canvas Dx, which uses an algorithm to analyze information submitted by parents and healthcare providers in addition to videos of the child to help guide decisions about diagnosis.

The Centers for Disease Control and Prevention estimates that autism affects 1 in 31 children. Many families face long waits to have their child evaluated for the developmental disability and the agency says that the median age of diagnosis is just under 4 years old.