TUEBINGEN, Germany--(BUSINESS WIRE)--German medical technology company AIRAmed has announced U.S. Food and Drug Administration 510(k) clearance of AIRAscore, a medical image management and processing system providing relevant brain volumetry data to assist physicians in early detection of Alzheimer’s and other dementias. AIRAscore uses deep learning and artificial intelligence (AI) technology to provide quantitative assessment of brain volume with objectively verifiable data using standard MRI brain scans in as little as five minutes.
According to the U.S. CDC, an estimated 5.8 million people in the United States have Alzheimer's disease and related dementias, including 5.6 million aged 65 and older and about 200,000 under age 65 with younger-onset Alzheimer's. Moreover, lifetime risk for Alzheimer’s at age 45 for women is one in five, and for men one in 10.1 Dementia has historically been diagnosed in more advanced stages, when potentially irreversible damage may have already occurred. Early and accurate detection is a key factor in positively influencing the course of the disease.
“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,” said Dr. Tobias Lindig, founder and managing director, AIRAmed, and specialist in both radiology and neurology at University Hospital Tübingen. “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. We believe our technology has the potential to be a game changer in the patient care journey, as brain volumes are of interest to physicians in the early disease course and also during the course of a disease to monitor the brain volume over time during therapy.”
AIRAscore provides physicians with a clear narrative and pictogram showing absolute values with accurate volumes of tissues and brain areas, standardized to each individual's anatomy. It compares volumes of individual brain areas to a large reference population, corrected for head size, age, and sex, and presents the information in an easily understandable manner similar to a blood laboratory report. Detailed information on the different lobes and limbic structures allows the identification of brain volumes that are not age appropriate, with different distribution patterns depending on the type of neurodegenerative disease. The technology therefore provides valuable information that supports physicians in the differentiated clarification of dementia forms, including Alzheimer’s Disease, frontotemporal dementia (FTD) as well as other dementias, movement disorders like atypical Parkinson syndromes and more diseases with known patterns of volume loss.
AIRAscore also offers auto segmentation of grey matter, white matter, CSF, and T1 hypointensities and provides detailed measurements of all brain lobes, midbrain and pons, hippocampus, cerebellum, and ventricular systems to support radiologists, neurologists, and other physicians with further quantitative evidence in diagnosing a suspected dementia. The software is extremely affordable and can be configured by a hospital’s or radiology facility’s IT department in less than an hour.
“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,” said Prof. Dr. Ahmed Othman, neuroradiologist, University Hospital Mainz, Germany. "This is a big milestone for early detection, differential diagnostics and disease monitoring in dementias."
AIRAscore has been used commercially in Europe for 4 years and will be available for purchase in the U.S. in the first quarter of 2024. Healthcare providers interested in demoing the software and learning more can contact info@airamed.de
About AIRAmed
AIRAmed is a medical technology company focused on the quantitative analysis of neuroradiological MRI image data. Its flagship product is AIRAscore, a medical image management and processing system providing relevant brain volumetry data to assist physicians in early detection of Alzheimer’s and other dementias.
AIRAscore uses deep learning and artificial intelligence (AI) technology to provide quantitative assessment of brain volume with objectively verifiable data using standard MRI brain scans in as little as five minutes.
1 Chene G, Beiser A, Au R, Preis SR, Wolf PA, Dufouil C, et al. Gender and incidence of dementia in the Framingham Heart Study from mid-adult life. Alzheimers Dement 2015;11(3):310-20.
