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VUNO Med®-DeepBrain® Receives FDA 510(k) Clearance

Monday, October 23, 2023

VUNO a South Korean medical AI company, has recently obtained FDA 510(k) clearance for its groundbreaking AI-based brain quantification tool, VUNO Med®-DeepBrain®. This technology streamlines the traditionally manual process of identifying and quantifying various brain structures from MRI images. It delivers volumetric data for over 100 brain regions, covering brain parcellation, cortical thickness, and white matter hyperintensity (WMH). The software also allows for the comparison of patient atrophy data against normative percentiles, enabling clinicians to access high-quality, quantifiable brain data.

This information holds significant potential for assisting in the diagnosis and management of conditions such as dementia and neurodegenerative diseases. Armed with FDA clearance, VUNO is now set to enhance its sales and marketing efforts, with a primary focus on targeting medical institutions in the United States.

The company also intends to strengthen its collaborations with globally renowned pharmaceutical companies seeking AI-driven brain MRI quantification technology. Notably, VUNO has previously explored the use of VUNO Med®-DeepBrain® for the early diagnosis of Alzheimer's disease, indicating its potential to aid in the early detection and management of patients at risk of progressing to dementia, even before the onset of Mild Cognitive Impairment (MCI) or early-stage dementia.