The U.S. Food and Drug Administration has cleared a new artificial intelligence tool that aids in the acquisition of magnetic resonance images, Seoul, South Korea-based developer Vuno announced Monday.
DeepBrain is intended to automate the manual process of identifying, labeling and quantifying brain structures from MRIs. Vuno estimates the AI software can provide volumetric data on over 100 brain regions via parcellation. It also gauges cortical thickness and white matter hyperintensity, comparing against population data to provide diagnostic insights.
This marks the first 510(k) clearance for Vuno and serves as a “steppingstone” for its expansion into the U.S.
“With this product, we will make every effort to help improve the declining quality of life experienced by many dementia patients,” CEO Yeha Lee said in an Oct. 23 ann0uncement.
Vuno noted that DeepBrain also can compile data and present it in a customizable format, which may prove valuable in assessing dementia and other neurodegenerative diseases. Following the FDA clearance, Lee and colleagues intend to bolster sales and marketing efforts in the U.S. and enhance collaboration with pharmaceutical firms seeking AI-based brain MRI quantification technology.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.