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.
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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.
Notably, the results provided by Neurora are intended for interpretation alongside a clinician’s other findings and professional judgment, and not as a standalone diagnostic.
“I’ve trained clinicians in autism assessment for years, and every evaluation comes down to clinical judgment where autism is just one of several questions we are asking,” said Latha Valluripalli, Argus’s co-founder and clinical lead and director of the Autism Assessment, Research, Treatment and Services (AARTS) Center at Rush University Medical Center.
“Neurora provides nuanced behavioural data, increases the confidence of observational data when collected by others, and facilitates clinician review of behaviours from the same session through the portal. The clinician still makes the call,” Vaulluripalli continued.
Other companies developing ASD diagnostics include Schweitzer Engineering Laboratories (SEL) and the Accelerate, Redesign, and Collaborate (ARC) innovation centre at Israel’s Sheba Medical Center. ARC partnered with Revealense in August 2025 to develop an AI-based behavioural analysis platform for ASD diagnosis that will take the form of a webcam for at-home evaluation.
HHS continuing to prioritise autism research
Neurora’s development was supported by a National Institutes of Health (NIH) small business innovation research (SBIR) grant at a time in which Robert F Kennedy Jr (RFK Jr) has promoted controversial views surrounding the root cause of autism, including the widely debunked claim that vaccines cause autism. The exact cause of autism remains unknown, but a combination of genetics and environmental factors are thought to play a role.
In 2025, RFK Jr pledged that the US Department of Health and Human Services (HHS) would find the cause of autism “by September”, but no such findings have yet been presented.
In September 2026, HHS agency the Advanced Research Projects Agency for Health (ARPA-H) launched the Systems for Phenotypic Evaluation, Clinical Trajectories, Response, and Agency (SPECTRA) programme, a research effort mooted to “transform” how autism is understood, diagnosed, and supported across the lifespan.
“Autism is not one-size-fits-all, and our science and care cannot be either,” said RFK Jr upon the programme’s launch.
“Millions of American families are impacted by autism, and they need better answers about why it presents so differently from one person to another and which approaches can best meet each person’s needs,” RFK Jr continued.
