Cortechs.ai Announces MFDS (KFDA) Approval of Global-Leading NeuroQuant® V5 Platform in South Korea

Feb. 25, 2026, Covington, KY – Cortechs.ai, a global leader in AI-driven medical imaging analysis, today announced that it has received regulatory approval from South Korea’s Ministry of Food and Drug Safety (MFDS), formerly known as KFDA, for the NeuroQuant® V5 product platform. This milestone expands Cortechs.ai’ footprint in the South Korean healthcare market and reinforces the company’s commitment to advancing clinical diagnostics and radiology workflows worldwide.

The newly approved NeuroQuant® V5 platform includes all advanced product segments: NeuroQuant®, NeuroQuant® MS, NeuroQuant ARIA. These AI-powered software solutions streamline complex imaging analysis and provide clinicians with objective, quantitative insights to enhance disease detection, monitoring, and treatment validation across multiple neurological care pathways.

NeuroQuant® supports the identification and evaluation of cerebral microhemorrhages on susceptibility-sensitive MRI sequences. These small focal brain lesions are commonly observed in patients with Traumatic Brain Injury (TBI), Cerebral Amyloid Deposition Diseases—including Cerebral Amyloid Angiopathy (CAA) and Alzheimer’s Disease (AD)—as well as patients experiencing Amyloid Related Imaging Abnormalities (ARIA).

New features in NeuroQuant® V5 include updated normative data with an expanded and refined database designed to better reflect a broader population, as well as improved normative curve calculations. By delivering precise, automated volumetric analysis and advanced visualization tools, NeuroQuant® V5 empowers healthcare professionals with greater confidence in diagnosing and monitoring complex neurological conditions.

“Receiving MFDS approval for NeuroQuant® V5, including NeuroQuant® ARIA, represents an important step forward for Cortechs.ai and for clinicians in South Korea,” said Kyle Frye, CEO of Cortechs.ai. “As the global demand for quantitative neuroimaging continues to grow, particularly in the era of emerging Alzheimer’s therapies, our mission is to provide objective, AI-driven insights that support clinical decision-making, improve workflow efficiency, and ultimately enhance patient care worldwide.”

With this approval, Cortechs.ai continues to expand global access to advanced neuroimaging AI solutions, supporting clinicians with objective volumetric data and color-coded brain structure analysis to complement clinical impressions and improve patient outcomes.

 

About Cortechs.ai

Cortechs.ai is a leader in AI applications in radiology, leveraging advanced technologies in medical imaging to enhance disease screening and early detection, empowering healthcare providers to deliver better outcomes for patients. The company develops and markets innovative medical imaging solution software for assessing neurological disorders such as Alzheimer’s disease, epilepsy, multiple sclerosis, brain trauma, tumors and prostate cancer, helping clinicians detect and monitor clinically significant cases. Cortechs.ai’s industry-leading imaging solutions offer radiologists, oncologists, and urologists a streamlined, cost-effective way to assess brain and prostate health, including cancer evaluation. Visit www.cortechs.ai for additional insights and follow us on Twitter, LinkedIn, and Facebook.

For more information, please contact:

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info@cortechs.ai 

+1 858 459 9700

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