• 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

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.

"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.