VUNO Secures FDA 510(k) Clearance for VUNO Med®-DeepBrain®
SEOUL, South Korea, Oct. 23, 2023 /PRNewswire/ -- VUNO Inc., 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®.
- SEOUL, South Korea, Oct. 23, 2023 /PRNewswire/ -- VUNO Inc., 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.
- With the FDA clearance in hand, VUNO intends to bolster its sales and marketing efforts targeting US medical institutions.
- VUNO has previously explored the potential for early diagnosis of Alzheimer's disease with information provided by VUNO Med®-DeepBrain® through clinical research.