Neurophet Secures FDA 510(k) Clearance for "Neurophet AQUA AD Plus, " Marking Its Third U.S. Regulatory Milestone
Neurophet Secures FDA 510(k) Clearance for "Neurophet AQUA AD Plus," Marking Its Third U.S. Regulatory Milestone |
| [06-February-2026] |
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. The FDA-cleared U.S. version of Neurophet AQUA AD Plus is an upgraded solution that builds upon the capabilities of Neurophet AQUA AD. Leveraging AI-based brain MRI analysis, the software automatically analyzes and quantifies: - Hypointense lesions associated with cerebral microbleeds and superficial siderosis, and - Hyperintense lesions related to brain edema By providing automated lesion localization and counts, the software helps clinicians more precise assess imaging-based risk factors and supports informed, patient-specific clinical decision-making when evaluating patients undergoing Alzheimer's disease-related therapeutic management. "Receiving FDA 510(k) clearance for Neurophet AQUA AD Plus represents a significant milestone that allows us to introduce our advanced Alzheimer's imaging technology more broadly in the U.S. market," said Jake Junkil Been, Co-CEO of Neurophet. "We plan to accelerate our expansion across the U.S. by strengthening collaborations with healthcare institutions and strategic partners." Neurophet AQUA AD Plus was previously designated as an Innovative Medical Technology in South Korea in September 2025. Building on this momentum, Neurophet plans to progressively expand clinical adoption of the solution across global healthcare settings, further broadening its global footprint in AI-based neuroimaging. About Neurophet Neurophet specializes in developing solutions for diagnosis support, treatment guides, and treatment devices targeting brain disorders based on cutting-edge artificial intelligence (AI) technology. The company was founded in 2016 by Co-CEOs Jake Junkil Been and Donghyeon Kim, who developed the next-generation neuro-navigation system. Major products include brain MRI analysis software "Neurophet AQUA", PET Image Quantitative Analysis Software "Neurophet SCALE PET", Brain imaging treatment planning software for electric and magnetic brain stimulation "Neurophet tES/TMS LAB", Alzheimer's Disease treatment prescription and monitoring software "Neurophet AQUA AD" for tracking treatment efficacy and side effects, and Multiple Sclerosis image analysis software "Neurophet AQUA MS". Neurophet has set its top priority to helping patients suffering from brain disorders. Based on expertise in neuroscience, Neurophet will continue to challenge and grow to explore the human brain's health and pioneer solutions for brain diseases with AI technology.
SOURCE Neurophet | ||
Company Codes: Korea:380550 |
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