VUNO, South Korean medical AI company, has received 510(k) clearance from the Food and Drug Administration (FDA) for its AI-powered brain quantification device, VUNO Med-DeepBrain.
VUNO Med-DeepBrain is intended to automate the current manual process of identifying, labeling, and quantifying segmentable brain structures from MRI images. The AI software efficiently provides volumetric data on over 100 brain regions through brain parcellation and provides cortical thickness, and white matter hyperintensity (WMH). The patients' atrophy data is compared with a normal population and displayed with a normative percentile measurement. This high quality, quantifiable brain data can be compiled and presented as a customizable report to clinicians, which may be valuable in dementia and other neurodegenerative diseases.
With the FDA clearance in hand, VUNO intends to bolster its sales and marketing efforts targeting U.S. medical institutions. Furthermore, the company plans to enhance its collaborations with globally recognized pharmaceutical firms seeking AI-based brain MRI quantification technology.
VUNO has previously explored the potential for early diagnosis of Alzheimer's disease with information provided by VUNO Med-DeepBrain through clinical research. According to clinical research presented at the Alzheimer's Association International Conference (AAIC) held in July 2023, VUNO Med-DeepBrain demonstrated its ability to provide information that can be used to predict amyloid positivity in patients experiencing Subjective Cognitive Decline (SCD), one of the earliest noticeable symptoms of Alzheimer's disease and related dementias.
This suggests that the product can contribute to the early detection and management of patients who may progress to dementia even before Mild Cognitive Impairment (MCI) or early dementia.