FDA Clears AI-Powered MRI Software for ARIA Detection in Patients with Alzheimer’s Disease
Icobrain.aria is reportedly the first AI software geared toward the detection and monitoring of amyloid-related imaging abnormalities (ARIAs) on brain MRI.
The Food and Drug Administration (FDA) has granted 510(k) clearance for icobrain.aria, an artificial intelligence (AI)-enabled software that may enhance the detection of amyloid-related imaging abnormalities (ARIAs) on brain MRI for patients being treated for Alzheimer’s disease.
Noting that ARIAs have been associated with recently approved disease-modifying agents for Alzheimer’s disease, Icometrix, the developer of icobrain.aria, said icobrain.aria is the first AI software dedicated to the diagnosis and monitoring of ARIAs in this patient population.
The images above reveal severe ARIA-E in a patient who presented with parenchymal edema. The AI-enabled software icobrain.aria, which was recently cleared by the FDA, demonstrated a 16 percent increase in sensitivity for ARIA-E and a 10 percent increase in sensitivity for ARIA-H, in a retrospective study published earlier this year in JAMA Network Open. (Images courtesy of JAMA Network Open.)
In a retrospective study published earlier this year in JAMA Network Open, icobrain.aria demonstrated a 16 percent increase in sensitivity for ARIA-E and a 10 percent increase in sensitivity for ARIA-H.
“New standardized tools are needed … to assist radiologists and treating clinicians in detecting and managing ARIA to optimize patient safety. I am excited that icobrain.aria has received FDA approval, clearing the way for wider use in clinical practice,” noted Stephen Salloway, M.D., the director of neurology and the Memory and Aging Program at Butler Hospital in Providence, R.I.
What is the Best Use of AI in CT Lung Cancer Screening?
April 18th 2025In comparison to radiologist assessment, the use of AI to pre-screen patients with low-dose CT lung cancer screening provided a 12 percent reduction in mean interpretation time with a slight increase in specificity and a slight decrease in the recall rate, according to new research.
New bpMRI Study Suggests AI Offers Comparable Results to Radiologists for PCa Detection
April 15th 2025Demonstrating no significant difference with radiologist detection of clinically significant prostate cancer (csPCa), a biparametric MRI-based AI model provided an 88.4 percent sensitivity rate in a recent study.
