NeuroXT Inc. Receives U.S. FDA 510(k) Clearance for NEXT-Cue, AI Software Supporting Prognostic Assessment in Mild Cognitive Impairment

• Supports clinicians in assessing progression from mild cognitive impairment to Alzheimer's dementia within five years
• NeuroXT Inc. to advance U.S. commercialization and adoption by healthcare institutions following FDA 510(k) clearance

SEOUL, South Korea, Oct. 20, 2026 /PRNewswire/ -- NeuroXT Inc., a medical device manufacturer, announced that NEXT-Cue, its AI-based Software as a Medical Device (SaMD) supporting prognostic assessment in patients with mild cognitive impairment (MCI), has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) as a Class II medical device.

NEXT-Cue supports clinicians in assessing patients with MCI who are being evaluated for progression to Alzheimer's dementia within five years. By integrating brain MRI images, demographic information, and cognitive assessment data, it provides supplementary information to support clinical assessment and individualized patient management planning.

"Receiving FDA 510(k) clearance marks an important milestone in NeuroXT's entry into the U.S. healthcare market," said Joon-Kyung Seong, CEO of NeuroXT Inc. "Starting with NEXT-Cue, we plan to establish real-world clinical use cases at leading healthcare institutions across the United States and accelerate our commercialization efforts, with the broader goal of contributing to earlier diagnosis and appropriate treatment of Alzheimer's disease."

NeuroXT Inc. is also pursuing regulatory authorization for NEXT-Cue from the Ministry of Food and Drug Safety (MFDS) in the Republic of Korea and plans to begin commercialization in the Korean market early next year.

About NeuroXT Inc.

NeuroXT Inc. is a medical AI company specializing in the development of AI-based imaging biomarkers for Alzheimer's disease. The company is developing AI technologies that primarily use MRI imaging to assess Alzheimer's disease-related pathology and potential treatment response. Through precision medicine solutions designed to help identify optimal treatment timing for individual patients, NeuroXT Inc. aims to advance the treatment of Alzheimer's disease.