Argus Cognitive’s Neurora can analyse routine appointment recordings for more than 100 vocal, facial and gaze signals in children aged 18 months to 12 years.
Argus Cognitive said the U.S. Food and Drug Administration has cleared its Neurora software to help clinicians support autism diagnoses in children from 18 months to 12 years old. The company said the tool is meant to add objective behavioural measurements to standard assessments, using video and audio recordings gathered during routine appointments rather than special equipment or a new testing protocol.
Autism affects about one in 31 children in the United States, according to the Centres for Disease Control and Prevention, while the average age of diagnosis remains close to four. Harvard Health has noted that autism assessments can be lengthy and that many children are diagnosed later than ideal, which can delay treatment during a key period of development. In that context, the clearance gives Argus Cognitive a foothold in a diagnostic market where clinicians have long relied primarily on observation and clinical judgement.
Neurora analyses recordings from behavioural assessments and measures more than 100 vocal, facial and gaze signals, according to the company. Under the FDA’s 510(k) pathway, which is used for devices cleared as substantially equivalent to existing products, the agency reviews whether a device is suitable for commercial distribution and whether changes could affect safety or effectiveness. An FDA database entry listed Neurora as a Class II paediatric autism diagnosis aid cleared on 2 October 2026.
Attila Meretei, Argus Cognitive’s chief executive and co-founder, said: “We built Neurora to support clinicians evaluating children for autism.” He added that the aim was to strengthen diagnoses with quantitative evidence. Latha Valluripalli Soorya, the company’s clinical lead, said: “The clinician still makes the call.” The firm also said development of the software was supported by the National Institutes of Health through a small business grant, with research carried out at Rush University Medical Centre, Sago Clinical Research, and sites in Qatar. Clinics interested in the product were directed to the company’s website.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
