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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.
Mammography News: FDA Grants Expanded 510(k) Clearance for AI-Powered SmartMammo Dx DBT Software
November 29th 2024Originally cleared by the FDA in 2021, the SmartMammo Dx software for digital breast tomosynthesis (DBT) can now be utilized with the Senographe Pristina mammography systems from GE HealthCare.
New Study Examines Short-Term Consistency of Large Language Models in Radiology
November 22nd 2024While GPT-4 demonstrated higher overall accuracy than other large language models in answering ACR Diagnostic in Training Exam multiple-choice questions, researchers noted an eight percent decrease in GPT-4’s accuracy rate from the first month to the third month of the study.
