Icometrix has gained approval to market its icobrain aria software in Europe, Israel, Japan, Switzerland, and the U.K.
Icobrain aria is designed for automated quantification of amyloid-related imaging abnormalities (ARIA) and severity scoring of ARIA-E (edema/sulcal effusion) and ARIA-H (hemorrhage/superficial siderosis). The software is now certified under European Union (EU) CE Medical Device Regulation (MDR) and otherwise registered in key regions, company officials told AuntMinnieEurope.com.
Icometrix expects that ARIA safety monitoring on regular brain MRI scans will play an important role in the follow-up of patients treated with amyloid beta-directed monoclonal antibodies for Alzheimer’s disease.
"Clinical trials have shown that these treatments can be associated with amyloid-related imaging abnormalities (ARIA),” Prof. Sebastiaan Engelborghs of the Vrije Universiteit Brussel in Belgium and Universitair Ziekenhuis Brussel Hospital said in a company announcement.
Icometrix also noted that it has been recommended that patients receive three brain MRI scans during the first year of treatment to detect and monitor ARIA. The software will aid radiologists and neurologists in assessing ARIA and prescribing anti-amyloid treatments, the company said.
In the U.S., icobrain aria is pending 510(k) approval from the U.S. Food and Drug Administration (FDA), Icometrix said.
![Overview of the study design. (A) The fully automated deep learning framework was developed to estimate body composition (BC) (defined as subcutaneous adipose tissue [SAT] in liters; visceral adipose tissue [VAT] in liters; skeletal muscle [SM] in liters; SM fat fraction [SMFF] as a percentage; and intramuscular adipose tissue [IMAT] in deciliters) from MRI. The fully automated framework comprised one model (model 1) to quantify different BC measures (SAT, VAT, SM, SMFF, and IMAT) as three-dimensional (3D) measures from whole-body MRI scans. The second model (model 2) was trained to identify standardized anatomic landmarks along the craniocaudal body axis (z coordinate field), which allowed for subdividing the whole-body measures into different subregions typically examined on clinical routine MRI scans (chest, abdomen, and pelvis). (B) BC was quantified from whole-body MRI in over 66,000 individuals from two large population-based cohort studies, the UK Biobank (UKB) (36,317 individuals) and the German National Cohort (NAKO) (30,291 individuals). Bar graphs show age distribution by sex and cohort. BMI = body mass index. (C) After the performance assessment of the fully automated framework, the change in BC measures, distributions, and profiles across age decades were investigated. Age-, sex-, and height-adjusted body composition reference curves were calculated and made publicly available in a web-based z-score calculator (https://circ-ml.github.io).](https://img.auntminnieeurope.com/mindful/smg/workspaces/default/uploads/2026/05/body-comp.XgAjTfPj1W.jpg?auto=format%2Ccompress&fit=crop&h=100&q=70&w=100)
![Overview of the study design. (A) The fully automated deep learning framework was developed to estimate body composition (BC) (defined as subcutaneous adipose tissue [SAT] in liters; visceral adipose tissue [VAT] in liters; skeletal muscle [SM] in liters; SM fat fraction [SMFF] as a percentage; and intramuscular adipose tissue [IMAT] in deciliters) from MRI. The fully automated framework comprised one model (model 1) to quantify different BC measures (SAT, VAT, SM, SMFF, and IMAT) as three-dimensional (3D) measures from whole-body MRI scans. The second model (model 2) was trained to identify standardized anatomic landmarks along the craniocaudal body axis (z coordinate field), which allowed for subdividing the whole-body measures into different subregions typically examined on clinical routine MRI scans (chest, abdomen, and pelvis). (B) BC was quantified from whole-body MRI in over 66,000 individuals from two large population-based cohort studies, the UK Biobank (UKB) (36,317 individuals) and the German National Cohort (NAKO) (30,291 individuals). Bar graphs show age distribution by sex and cohort. BMI = body mass index. (C) After the performance assessment of the fully automated framework, the change in BC measures, distributions, and profiles across age decades were investigated. Age-, sex-, and height-adjusted body composition reference curves were calculated and made publicly available in a web-based z-score calculator (https://circ-ml.github.io).](https://img.auntminnieeurope.com/mindful/smg/workspaces/default/uploads/2026/05/body-comp.XgAjTfPj1W.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
