FDA clears AI tool for early Alzheimer’s detection from MRI scans

AIRAmed receives FDA 510(k) clearance for AI-powered brain volumetry software.
German medtech company AIRAmed has received FDA 510(k) clearance for its AIRAscore brain volumetry software that supports early detection of Alzheimer’s disease and other forms of dementia. The software tool uses AI and deep learning to generate brain volumetry data using standard MRI scans within five minutes.

AIRAmed’s flagship product, AIRAscore provides quantitative analysis of neuroradiological MRI image data, providing physicians with a comprehensive overview of brain volumetry data. Information is presented in the form of a clear narrative and pictogram, presenting absolute values and accurate volumes of brain tissues and areas tailored to an individual’s unique anatomy. The tool also compares these volumes to a substantial reference population while adjusting for factors like age, sex, and head size, mirroring the format of a typical blood laboratory report.

Having already been commercially available in Europe for four years, AIRAscore is now expected to be accessible in the US market in the first quarter of 2024.

“This is a big milestone for early detection, differential diagnostics and disease monitoring in dementias,” said Professor Ahmed Othman, neuroradiologist at University Hospital Mainz, Germany. “The innovative brain volumetry system AIRAscore offers new possibilities in diagnosis and treatment of neurodegenerative diseases with an easily accessible surrogate parameter of disease activity.”

AIRAscore’s capabilities extend beyond Alzheimer’s disease, supporting the differentiation of frontotemporal dementia, and other dementia types, as well as movement disorders like atypical Parkinson syndromes. This is down to the product’s ability to identify patterns of volume loss specific to each condition, providing valuable insights to support accurate diagnoses.

AIRAscore also includes auto segmentation of key brain components such as grey matter, white matter, cerebrospinal fluid (CSF), and T1 hypointensities. It also measures brain lobes, midbrain, pons, hippocampus, cerebellum, and ventricular systems.

“For so long, we’ve been limited to reading a patient’s MRI to detect Alzheimer’s and other dementias,” said Dr Tobias Lindig, founder of AIRAmed. “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. 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.”

FDA clears AI tool for early Alzheimer’s detection from MRI scans