Argus Cognitive’s paediatric autism diagnostic secures FDA clearance

Argus's Neurora tool is intended to complement clinicians' professional judgement rather than serve as a standalone diagnostic for autism.

Argus Cognitive’s Neurora has secured US Food and Drug Administration (FDA) clearance, providing clinicians with a tool to support the diagnosis of autism spectrum disorder (ASD) in paediatric patients.

Neurora is designed to provide clinicians with objective behavioural measures to support the diagnosis of the neurodevelopmental disorder in children between 18 months and 12 years of age.

Clinicians start by uploading video and audio from a standard behavioural assessment to Neurora’s digital portal. In measuring over 100 vocal, facial and gaze biometrics, the artificial intelligence (AI)-based Class II software as a medical device (SaMD) analyses how closely a child’s behaviour aligns with that of children with and without an autism diagnosis to support a diagnosis of the condition.

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