A new AI tool that can help identify and quantify brain structures from MRI scans has been cleared by the US Food and Drug Administration (FDA).
The tool, developed by South Korea-based AI medical software company VUNO, is called the Med-DeepBrain.
In a press release announcing the FDA 510(k) clearance, VUNO said the goal of the device is to automate identifying, labelling and quantifying segmented brain structures on MRI scans, a process that radiologists currently manually conduct.
The FDA clearance is the first for VUNO’s AI portfolio.
The AI software provides volumetric data on over 100 brain regions through brain parcellation and also provides measurements of cortical thickness and white matter hyperintensity (WMH).
A patient’s brain atrophy data is compared with that of a normal population and displayed with a normative percentile measurement.
VUNO said 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.
Yeha Lee, CEO of VUNO said, “VUNO Med-DeepBrain marks the first FDA clearance from VUNO, and we expect it will be a steppingstone for VUNO’s expansion into the US market,” adding “with this product, we will make every effort to help improve the declining quality of life experienced by many dementia patients.”
The FDA clearance means clinicians can use the software to extract information from MRI scans.
With the FDA clearance, VUNO said it intends to boost its sales and marketing efforts towards US medical institutions. The company said it also plans to foster collaborations with pharmaceutical companies around the world interested in using AI tools to extract data from MRI brain scans.
VUNO said it’s also been exploring the use of Med-DeepBrain to help gather information that could aid in the early detection of dementia and other neurodegenerative diseases including Alzheimer’s disease.
The company said it presented some of its clinical research at the Alzheimer’s Association International Conference (AAIC) held in July 2023, in which VUNO Med-DeepBrain demonstrated an 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.
VUNO said this suggests that the tool can potentially assist in the early detection and management of patients who may progress to dementia even before mild cognitive impairment (MCI) or early dementia.
VUNO’s range of AI-powered diagnostic platforms include evaluation of bone age from X-ray images, retinal disease screening, pulmonary lung nodule detection on CT images and cardiac risk detection software.
The integration of AI technology in medical imaging is growing rapidly. According to a 2023 GlobalData report, it is predicted that the global revenue for AI platforms across healthcare will reach $18.8 billion by 2027.