AI brain imaging device receives FDA clearance
South Korean startup Vuno’s AI-powered brain imaging device has received the 510(k) certification from the U.S. Food and Drug Administration (FDA), signaling the company’s expansion into U.S. markets where it hopes to improve the early diagnosis of dementia.
The Vuno Med-DeepBrain automatically enhances MRI images, segmenting the brain into 100 distinct areas to identify and measure any reduction in brain activity almost immediately. The technology is designed to assist clinicians in the diagnosis of neurodegenerative conditions and dementia, including Alzheimer’s, providing more imaging data than what’s possible with just an MRI.
