FDA Gives Nod to Automated Software for ARIA Monitoring

The Food and Drug Administration (FDA) has granted 510(k) clearance to Icobrain Aria (Icometrix, Boston, MA), a software that provides computer-assisted, automatic detection and severity grading for amyloid-related imaging abnormalities (ARIA). Icobrain Aria generates a quantitative summary report for MRI images, including severity rating scores based on the measurement and summarization of ARIA cerebral edema (ARIA-E) and ARIA cerebral microhemorrhages (ARIA-H) sites of involvement.

According to a statement from Icometrix, the approval was based on results of a study demonstrating that the use of Icobrain Aria was associated with significantly increased accuracy in ARIA assessment by radiologists. The software has utility in the treatment of Alzheimer disease (AD) using amyloid-targeting monoclonal antibody (mAb) disease-modifying therapies (DMTs). The labels for the FDA-approved medications Leqembi (lecanemab-irmb; Eisai, Tokyo, Japan; Biogen, Cambridge, MA) and Kisunla (donanemab; Eli Lilly and Company, Indianapolis, IN) both carry Boxed Warnings for ARIA, requiring MRI monitoring for the condition. Icobrain Aria is intended to provide a less labor- and time-intensive method for monitoring for ARIA.

“Icobrain Aria was thoroughly evaluated in large reader studies,” said Jeffrey L. Cummings, MD, ScD, Director of the Chambers-Grundy Center for Transformative Neuroscience at the University of Nevada, Las Vegas. “It was demonstrated that the assistance of AI significantly improved radiologists’ ability to detect and classify ARIA, boosting both diagnostic sensitivity and accuracy, and adding a critical safety option for patients undergoing amyloid-targeting therapies.”