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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

510(k)

Argus Cognitive clears Neurora under K260064 to score autism assessment video

MedDevice Startups Staff · Oct 8 · 2 min read · Via Medical Device Network

Argus Cognitive cleared Neurora under K260064, announced October 8. The Class II software analyzes video and audio from a standard autism behavioral assessment. It scores more than 100 vocal, facial and gaze biometrics and reports how closely a child's behavior matches children with and without an autism diagnosis.

The indication covers patients 18 months through 12 years. Neurora is an aid, not a standalone diagnostic, and the clinician makes the call. Clinicians upload the session to a portal, so the workflow needs no protocol change and no proprietary hardware.

Argus Cognitive was founded in 2016 in Hanover, New Hampshire, by chief executive Attila Meretei and clinical lead Latha Valluripalli Soorya, who directs the autism assessment center at Rush University Medical Center. An NIH SBIR grant funded the development. Clearing a behavioral scoring tool that runs on ordinary clinic video is a cheaper adoption story than anything needing a new camera rig in the exam room.

Questions & Answers

What is the FDA K number for Argus Cognitive's Neurora?

Neurora was cleared under 510(k) K260064, announced October 8, 2026. It is a Class II software device from Argus Cognitive that aids autism spectrum disorder diagnosis in children.

What age range is Argus Cognitive's Neurora cleared for?

Neurora is cleared for patients aged 18 months through 12 years. Argus Cognitive says it is an aid to diagnosis rather than a standalone diagnostic, and results are interpreted alongside the clinician's other findings.

How does Argus Cognitive's Neurora work?

Clinicians upload video and audio from a standard behavioral assessment to the Neurora portal. The software measures more than 100 vocal, facial and gaze biometrics and reports how closely the child's behavior aligns with children who do and do not have an autism diagnosis. No protocol change or proprietary hardware is required.

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