AI-Based Brain Volumetric Software, VUNO Med-DeepBrain, Receives FDA 510(k) Clearance

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VUNO announced that the Food and Drug Administration (FDA) has granted the company 510(k) clearance to market VUNO Med-DeepBrain (VUNO, Seoul, South Korea) in the United States. VUNO Med-DeepBrain is an artificial intelligence (AI)-based software that extracts quantitative data of the brain from MRI scans. The software uses brain parcellation to provide volumetric data on multiple brain regions, while also evaluating white matter hyperintensity (WMH) and cortical thickness.

The quantified brain data that VUNO Med-DeepBrain produces through its analyses have potential applications in the diagnosis of Alzheimer disease (AD) and other neurodegenerative conditions that cause brain volume change and atrophy. The software compares an individual patient’s atrophy data to healthy populations and provides normative percentile scores and volume information to health care providers (HCPs) in the form of a customizable report containing statistical analysis results, visualized graphs, and diagrams. Based on data presented at the 2023 meeting of the Alzheimer’s Association International Conference (AAIC), VUNO Med-DeepBrain’s brain quantification data were demonstrably effective when implemented to predict amyloid positivity in people with subjective cognitive decline (SCD). 

“VUNO Med®-DeepBrain® marks the first FDA clearance from VUNO, and we expect it will be a steppingstone for VUNO's expansion into the U.S. market,” said Yeha Lee, CEO of VUNO. “With this product, we will make every effort to help improve the declining quality of life experienced by many dementia patients.”

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