VUNO wins FDA approval for AI-based brain imaging analysis medical device

VUNO Med-DeepBrain [Courtesy of VUNO]

South Korean healthcare artificial intelligence (AI) solutions company VUNO Inc. announced on Tuesday that its AI-based brain imaging analysis medical device, “VUNO Med-DeepBrain,” has obtained certification from the U.S. Food and Drug Administration (FDA).

This is the first time the company’s product has received FDA certification.

VUNO Med-DeepBrain is a medical device that analyzes brain magnetic resonance imaging, or MRI, based on deep learning, by dividing the brain into over 100 regions and providing quantified information on the degree of atrophy in each region. This assists medical professionals in diagnosing conditions such as Alzheimer’s disease and vascular dementia.

VUNO plans to strengthen its business and marketing efforts targeting U.S. medical institutions via its U.S. subsidiary while also pursuing partnerships with global pharmaceutical companies and other entities.

In July, VUNO announced a study showing that VUNO Med-DeepBrain can be used to diagnose patients with “subjective cognitive decline,” a stage before the onset of full-blown dementia symptoms.

“We expect VUNO Med-DeepBrain to be the cornerstone of our expansion into the U.S. market,” VUNO Chief Executive Officer Lee Ye-ha said. “With the recent advent of next-generation dementia treatments, there is a growing demand for early diagnosis, and we will strengthen our sales efforts to rapidly expand this product in the U.S. market and contribute to solving the problem of dementia.”