AIRAmed's AIRAscore Brain Volumetry Software Secures FDA 510(k) Clearance

Wednesday, September 20, 2023

AIRAmed, a German medical technology company, has recently received FDA 510(k) clearance for its AIRAscore system. This advanced medical image management and processing solution are aimed at assisting healthcare professionals in the early detection of Alzheimer's disease and other forms of dementia.

AIRAscore leverages deep learning and artificial intelligence (AI) technologies to provide a rapid and quantitative assessment of brain volume based on standard MRI brain scans, reducing the evaluation time to just five minutes. It offers physicians a clear and customized report, complete with precise values for various brain tissues and regions, tailored to each patient's unique anatomy.

Furthermore, AIRAscore includes automated segmentation capabilities for grey matter, white matter, cerebrospinal fluid (CSF), and T1 hypointensities. It also provides comprehensive measurements of brain lobes, midbrain and pons, hippocampus, cerebellum, and ventricular systems. These detailed metrics serve as valuable quantitative evidence to aid radiologists, neurologists, and other medical practitioners in the diagnosis of suspected dementia cases.

Another notable feature of AIRAscore is its cost-effectiveness and ease of implementation. Hospitals and radiology facilities can have the system configured by their IT departments in less than an hour.This innovative brain volumetry system by AIRAmed opens up new possibilities for diagnosing and managing neurodegenerative diseases, offering an accessible parameter for assessing disease activity.


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