GE Healthcare's Omnyx integrated digital pathology (IDP) product with the new VL120 high-volume scanner has received a CE Mark for primary diagnosis in Europe under the EU's in vitro devices directive, the company said.
The approval represents an upgrade from last year's CE clearance, when Omnyx IDP was approved for use with the Omnyx VL4 slide scanner for lower-volume uses, the company said. That product has been placed in Switzerland, Spain, and the U.K.
The higher volume scanner offers histopathologists greater speed and efficiency for scanning slides, creating case files, and managing their workflow, GE said. Omnyx IDP was developed by a joint venture of GE Healthcare and the University of Pittsburgh Medical Center in Pennsylvania, GE added.
Until now there has been a dearth of investment in technology for pathologists, who often have to travel to remote laboratories or wait to receive slides, creating delays in diagnosis and a risk of damage or loss, GE 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&dpr=2&fit=crop&h=167&q=70&w=250)
