FDA Clears Second AI Tool That Scores Five-Year Risk of MCI Progressing to Alzheimer's

NEXT-Cue, a Class II device from South Korea-based NeuroXT, folds brain MRI, patient demographics and cognitive test scores into a single prognostic readout for people already diagnosed with mild cognitive impairment. It is only the second product cleared under a device category the FDA created in 2024.

The U.S. Food and Drug Administration has granted 510(k) clearance to NEXT-Cue, an AI-based software program from NeuroXT Inc. that combines brain MRI images, patient demographic data and cognitive test scores to help clinicians assess whether a patient with mild cognitive impairment (MCI) is likely to progress to Alzheimer's dementia within five years, the company announced on October 20, 2026. The FDA classified NEXT-Cue as a Class II device, meaning it is subject to general controls plus device-specific special controls, and the company says the software is meant to supply supplementary information for clinical assessment and care planning, not to make a diagnosis on its own.

NEXT-Cue is only the second device cleared under this particular FDA category, "prognostic assessment software of mild cognitive impairment," which the agency created through a De Novo authorization in January 2024 for a different product, BrainSee, made by Darmiyan Inc. That FDA decision summary defines the category as software that merges multiple clinical data sources to output a likelihood of progression to more severe impairment or dementia, and it explicitly states the device type is "intended for adjunctive use and not intended as a stand-alone diagnostic or prognostic tool." The same FDA document notes that in human-factors testing of the original device in this category, a small number of users did not understand what the device's output or its indications actually meant.

What is missing so far is any public, agency-reviewed summary of how accurately NEXT-Cue itself performs. NeuroXT's announcement describes what the software does and how it is used, but it does not disclose a sample size, a study population, a time frame, or performance statistics such as sensitivity or specificity for NEXT-Cue's own validation, and the FDA had not yet posted its own public 510(k) summary for the device as of this writing. The only validation data tied to this device category that has been made public, from the 2024 De Novo decision for BrainSee, came from a retrospective study using data collected at 27 North American sites, not from a trial of NEXT-Cue.

NeuroXT, a Seoul-based medical AI company, said it plans to pursue adoption at U.S. healthcare institutions and is separately seeking authorization from South Korea's Ministry of Food and Drug Safety, with commercialization there targeted for early next year.

For now, families encountering a NEXT-Cue style score should understand it as one input among several that a clinician weighs, not a stand-alone answer about what will happen next; the device's own FDA-defined category bars it from being used that way.