Hanover, N.H.-based Argus Cognitive’s Neurora, a software tool that analyzes behavioral data to assist clinicians in diagnosing autism in children ages 18 months through 12 years, received FDA clearance.
The tool analyzes video and audio recordings collected during standard behavioral assessments, measuring more than 100 vocal, facial and gaze biometrics, according to an Oct. 8 news release from the company. It then compares those measurements with behavioral patterns observed in children with and without an autism diagnosis.
Neurora is classified as a Class II pediatric autism spectrum disorder diagnosis aid and does not require clinicians to change their existing assessment protocols or use proprietary hardware. The results are intended to inform clinical decision-making rather than provide a standalone diagnosis.
The technology’s development received support from a National Institutes of Health Small Business Innovation Research grant. Earlier research, published this year in Frontiers in Psychiatry, was conducted at Rush University Medical Center and Sago Clinical Research, both in Chicago, and at the Qatar Biomedical Research Institute in Doha, Qatar. The most recent clinical study was conducted with partners including LSU Health Shreveport, Autism Testing 4 Kids and Ascend Behavior Partners.
The clearance comes as autism affects 1 in 31 U.S. children, according to CDC data cited by the company. The median age of diagnosis is nearly 4, with only about half of autistic children evaluated by age 3.
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