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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

The Tracker / October 2026 / K260064

510(k) cleared

Neurora

Argus Cognitive, Inc. · Oct 2, 2026 · K260064 · In the directory

FDA cleared the Neurora from Argus Cognitive, Inc. on Oct 2, 2026 under K260064, a traditional 510(k). The device falls under product code QPF, Pediatric Autism Spectrum Disorder Diagnosis Aid, regulated at 21 CFR 882.1491 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jan 9, 2026. The decision came 266 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Argus Cognitive, Inc. has one other decision in the tracker over the last 12 months: K251417 (ReVISION 2).

Questions & Answers

What did FDA clear under K260064?

K260064 is the FDA 510(k) for Neurora, submitted by Argus Cognitive, Inc.. FDA's decision date was Oct 2, 2026, under product code QPF (Pediatric Autism Spectrum Disorder Diagnosis Aid).

Who makes the Neurora?

Argus Cognitive, Inc., based in Hanover, NH, is the applicant of record for K260064. The company is listed in the MedDevice Startups directory.

How long did the K260064 review take?

FDA received the submission on Jan 9, 2026 and issued its decision on Oct 2, 2026, 266 days later.

← All decisions in October 2026

Sources

In the startup directory

Argus Cognitive

Diagnostics & IVD · Hanover, NH