FDA clears AI-powered brain MRI evaluation software
The U.S. Food and Drug Administration (FDA) has approved a new tool for the early detection of dementia. AIRAmed, a German healthcare technology company, has been granted FDA 510(k) clearance for AIRAscore, a medical image management and processing system. The advanced artificial intelligence (AI) platform is now on its way to being deployed throughout the U.S.
The newly approved system was designed to use deep learning to assist with the detection of Alzheimer's disease and other forms of dementia. Dementia is typically diagnosed in more advanced stages, when potentially irreversible damage may have already occurred. The early and accurate detection of dementia is a critical step toward providing high-quality care.
Patients simply need to undergo an MRI of their brain for the AIRAscore to begin working. The scanned images are then anonymized and securely transmitted off-site, and then results are returned to the hospital or medical center after being evaluated. The system measures brain areas, comparing them to a reference population, accounting for age, sex and head size. The result is a final report that includes the information physicians need to make a diagnosis and better understand the patient’s prognosis.
AIRAscore offers an automated segmentation of gray matter, white matter, cerebrospinal fluid, and T1 hypointensities. The software furnishes comprehensive measurements of various brain regions, including the brain lobes, midbrain, pons, hippocampus, cerebellum and ventricular systems. It then provides this quantitative brain volume assessment data to physicians within minutes, allowing them to identify abnormal brain images and activity linked to neurodegenerative diseases and movement disorders.
"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,” radiologist Tobias Lindig, MD, founder and managing director of AIRAmed, said in a statement. “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, in use in Europe for four years, will be available in the U.S. in early 2024.
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