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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 / K261805

510(k) cleared

NEXT-Cue

Neuroxt, Inc. · Oct 8, 2026 · K261805

FDA cleared the NEXT-Cue from Neuroxt, Inc. on Oct 8, 2026 under K261805, a traditional 510(k). The device falls under product code QWT, Prognostic Assessment Software Of Mild Cognitive Impairment, regulated at 21 CFR 882.1454 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jun 1, 2026. The decision came 129 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Neuroxt, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261805?

K261805 is the FDA 510(k) for NEXT-Cue, submitted by Neuroxt, Inc.. FDA's decision date was Oct 8, 2026, under product code QWT (Prognostic Assessment Software Of Mild Cognitive Impairment).

Who makes the NEXT-Cue?

Neuroxt, Inc., based in Seoul, is the applicant of record for K261805.

How long did the K261805 review take?

FDA received the submission on Jun 1, 2026 and issued its decision on Oct 8, 2026, 129 days later.

← All decisions in October 2026