Isotope technology firm Eckert & Ziegler received approval from the Federal Institute for Drugs and Medical Devices for its pharmaceutical germanium-68 (Ge-68)/gallium-68 (Ga-68) generator for the German market.
It is the first approved generator to use a radionuclide for PET in the diagnosis of cancer and meets the requirements for pharmacopoeia monographs, according to the firm.
Gallium generators provide an inexpensive alternative for radiolabeling biomolecules using PET. Until now, fluorine-18 or carbon-11 radioisotopes have generally been used to radiolabel biomolecules; the radioisotopes are produced using cyclotrons, large-scale installations that require millions in investment, according to Eckert & Ziegler. The Ge-68/Ga-68 generator is approximately the size of a thermos and can be sourced much more inexpensively, the firm added.
Eckert & Ziegler has submitted its documents for the generator to the U.S. Food and Drug Administration, establishing a Drug Master File with the agency. Approval for sale in additional European countries has already been granted.
![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)
