French medical imaging company Guerbet (Euronext Paris:GBT) announced on Tuesday that it has received approval from the European Commission for a new indication in children from birth for its macrocyclic high-relaxivity gadolinium-based contrast agent, Elucirem (gadopiclenol), in the European Union.

Elucirem was initially approved in the EU in December 2023. It is produced in France and in the USA and is marketed by Guerbet in vials and prefilled syringes.

In the European Union, Elucirem is indicated in adults and in children now from birth, for contrast-enhanced magnetic resonance imaging (MRI) to improve detection and visualisation of pathologies with disruption of the blood-brain-barrier (BBB) and/or abnormal vascularity of the brain, spine, and associated tissues of the central nervous system (CNS), as well as the liver, kidney, pancreas, breast, lung, prostate, and musculoskeletal system. For these indications, the company says that an MRI examination with Elucirem requires half the conventional dose compared to that required with existing nonspecific contrast agents, thus answering a major concern of practitioners about gadolinium exposure.