Neurophet Secures FDA 510(k)

Neurophet Secures FDA 510(k) Clearance for “Neurophet AQUA AD Plus,” Marking Its Third U.S. Regulatory Milestone

February 6, 2026
9:36 pm

SEOUL, South Korea, Feb. 6, 2026 /PRNewswire/ -- Neurophet (Co-CEOs Jake Junkil Been and Donghyeon Kim), an artificial intelligence (AI) solution company for brain disorders diagnosis and treatment, announced today that its software solution, Neurophet AQUA AD Plus, a comprehensive neuroimaging analysis solution for clinical evaluation related to Alzheimer's disease, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

This clearance marks Neurophet’s third FDA 510(k) clearance, following Neurophet AQUA, a brain neurodegeneration imaging analysis software, and Neurophet SCALE PET, a PET image quantitative analysis software. The achievement further validates the safety and effectiveness of Neurophet’s core product portfolio at a global regulatory standard.

Neurophet AQUA AD Plus is a software-based solution designed to support imaging-based clinical evaluation across the Alzheimer’s disease care continuum. The software performs quantitative analysis of MRI and PET images, enabling automated labeling, visualization, volumetric quantification of brain structures and lesions, as well as standardized uptake value ratio (SUVR) analysis. Quantitative results can be compared with normative reference data to support the evaluation of neurodegeneration and cognitive impairment.

Neurophet Secures FDA 510(k) Clearance for “Neurophet AQUA AD Plus,” Marking Its Third U.S. Regulatory Milestone

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