FDA Clears AI-Powered Brain Volumetry Software for MRI

The Food and Drug Administration (FDA) has granted 510(k) clearance for AIRAscore, an artificial intelligence (AI)-powered software that may facilitate earlier detection of Alzheimer’s disease and other forms of dementia through quantitative brain volume analysis based on magnetic resonance imaging (MRI) scans.

AIRAMed, the developer of the AIRAscore, said the software provides detailed assessment of lobes and limbic structures in the brain to help detect patterns of neurodegenerative disease and brain volumes that are not age appropriate. The company added that other benefits of the software include auto-segmentation of white matter, cerebrospinal fluid, grey matter and T1 hypointensities.

The AIRAscore findings can be beneficial in detecting and differentiating between Alzheimer’s disease, frontotemporal dementia, and other diseases with patterns of brain volume loss, according to AIRAMed.

“For so long, we’ve been limited to reading a patient’s MRI to detect Alzheimer’s and other dementias. However, we know from several studies that patients with these brain diseases suffer from subtle brain volume loss early in their disease course that cannot be observed with the human eye,” noted Tobias Lindig, M.D., the founder and managing director of AIRAMed. “With AIRAscore, we are now offering physicians a highly precise, quantitative tool for the rapid detection of areas with a brain volume below the normal range.”