FDA clears Neurora, a video-based tool designed to speed autism assessments

Neurora analyses facial expression, voice pattern and eye gaze to support clinicians assessing children aged 18 months to 12 years, but is not intended to replace professional judgement.

Federal regulators have cleared a new software-based tool that is designed to help clinicians identify autism in children, adding another option to a small but growing field of diagnostic aids.

The Food and Drug Administration authorised Neurora this month for use in children aged 18 months to 12 years, according to Disability Scoop. The system, developed by Argus Cognitive, is intended to support diagnosis rather than replace it, with the company saying the output should be weighed alongside other clinical findings and professional judgement.

Argus Cognitive says clinicians can upload video and audio captured during routine behavioural assessments to the Neurora portal, where the system analyses more than 100 biometric signals. Those include facial expression, voice pattern and eye gaze, all of which are compared with data from children with and without autism. Chief executive and co-founder Attila Meretei said the company built the product to fit into assessments already in use, without requiring changes to testing protocols or specialised hardware.

The company says development of the tool was backed by a National Institutes of Health grant for entrepreneurs. Disability Scoop reported that an earlier study found Neurora could distinguish between autistic and non-autistic children in nearly 78% of cases, though that still leaves room for error and underlines why clinicians are being told to use it as one part of a broader evaluation.

Neurora joins a short list of FDA-cleared autism assessment devices. Earlier clearances include EarliPoint Evaluation for ASD, which uses eye-tracking technology, and Canvas Dx, which relies on an algorithm that incorporates parent and provider information as well as video of the child. The backdrop is a growing need: the Centres for Disease Control and Prevention estimates autism affects one in 31 children, and says the median age of diagnosis is just under four, a figure that reflects the long waits many families still face.

Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.