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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.
The Pearl White Edition of DJI's Breakthrough Dual-Lens Gimbal Camera Offers 17 Stops of Dynamic Range, 10-bit HDR Video, and Advanced D-Log 2 Color Science SHENZHEN, China, Oct. 20, 2026 /PRNewswire/ -- DJI, the global leader in civilian drones and creative camera technology, today...
An investigation by Wired and privacy research firm Redact has revealed that Meta embedded hidden instructions within the source code of roughly 80 WhatsApp help and FAQ pages, directing its AI support chatbot on "what not to say" regarding legal advice, privacy laws, and data protection authorities.
Discover how to add Emirates ID, driving licence, and vehicle registration to your smartphone wallet for seamless access in the UAE.
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