FDA Clears MRI-Based AI Software for Prognostic Evaluation of Patients with Mild Cognitive Impairment
The NEXT-Cue AI software, which incorporates analysis of brain MRI scans, reportedly facilitates prognostic assessments of potential progression from mild cognitive impairment (MCI) to Alzheimer’s disease within five years.
The Food and Drug Administration (FDA) has granted 510(k) clearance for the AI-powered software NEXT-Cue, which may provide long-term prognostic insights for patients with mild cognitive impairment (MCI).
Combining assessment of brain MRI scans, cognitive evaluation and demographic information, the
The company noted that the NEXT-Cue software offers prognostic insights for the possible progression of MCI to Alzheimer’s disease within five years.
“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.”
Related to this article
