Neurophet Receives Third FDA 510(k) Clearance for AI-Powered Alzheimer's Imaging Analysis Software
核心洞察
South Korean AI company Neurophet (搜索) secured FDA 510(k) clearance for Neurophet AQUA AD Plus (搜索), marking its third regulatory milestone in the United States.
The software performs automated quantitative analysis of MRI and PET images to support clinical evaluation across the Alzheimer's disease (搜索) care continuum.
The AI-based solution automatically analyzes hypointense lesions associated with cerebral microbleeds (搜索) and hyperintense lesions related to brain edema (搜索).
South Korean artificial intelligence company Neurophet (搜索) has received FDA 510(k) clearance for its Neurophet AQUA AD Plus (搜索) software, a comprehensive neuroimaging analysis solution designed for clinical evaluation related to Alzheimer's disease (搜索). This marks the company's third FDA regulatory milestone, following previous clearances for Neurophet AQUA (搜索) brain neurodegeneration (搜索) imaging analysis software and Neurophet SCALE PET (搜索) image quantitative analysis software.
Advanced AI-Powered Neuroimaging Analysis
Neurophet AQUA AD Plus (搜索) is a software-based solution designed to support imaging-based clinical evaluation across the Alzheimer's disease (搜索) care continuum. The software performs quantitative analysis of MRI and PET images, enabling automated labeling, visualization, and 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 (搜索) and cognitive impairment (搜索).
The FDA-cleared U.S. version represents an upgraded solution that builds upon the capabilities of Neurophet AQUA (搜索) AD. Leveraging AI-based brain MRI analysis, the software automatically analyzes and quantifies hypointense lesions associated with cerebral microbleeds (搜索) and superficial siderosis, as well as hyperintense lesions related to brain edema (搜索).
Clinical Decision-Making Support
By providing automated lesion localization and counts, the software helps clinicians more precisely assess imaging-based risk factors and supports informed, patient-specific clinical decision-making when evaluating patients undergoing Alzheimer's disease (搜索)-related therapeutic management.
"Receiving FDA 510(k) clearance for Neurophet AQUA AD Plus (搜索) 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 (搜索). "We plan to accelerate our expansion across the U.S. by strengthening collaborations with healthcare institutions and strategic partners."
Regulatory Recognition and Market Expansion
The achievement validates the safety and effectiveness of Neurophet (搜索)'s core product portfolio at a global regulatory standard. Neurophet AQUA AD Plus (搜索) 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.
Company Background
Neurophet (搜索) specializes in developing solutions for diagnosis support, treatment guides, and treatment devices targeting brain disorders based on cutting-edge artificial intelligence technology. The company was founded in 2016 by Co-CEOs Jake Junkil Been and Donghyeon Kim, who developed the next-generation neuro-navigation system.
The company's major products include brain MRI analysis software "Neurophet AQUA (搜索)", PET Image Quantitative Analysis Software "Neurophet SCALE PET (搜索)", Brain imaging treatment planning software for electric and magnetic brain stimulation "Neurophet (搜索) tES/TMS LAB", Alzheimer's Disease (搜索) treatment prescription and monitoring software "Neurophet AQUA AD" for tracking treatment efficacy and side effects, and Multiple Sclerosis (搜索) image analysis software "Neurophet AQUA MS".