Abstract
Iron oxide nanoparticles (IONPs) demonstrate substantial translational potential in precision medicine, leveraging their favourable biocompatibility and distinctive magnetic properties. This comprehensive review systematically analyses their established clinical applications including magnetic resonance imaging (MRI) contrast enhancement, oncological interventions, and iron deficiency therapies. It further examines the critical design parameters governing the performance, safety, and metabolic fate of IONPs from a clinical-translational perspective. It addresses pivotal challenges in their clinical application and translation, including synthetic reproducibility, scalable manufacturing, and long-term biosafety, while also reviewing recent promising advances aimed at overcoming these hurdles. Furthermore, the translational potential of emerging preclinical innovations, including magnetic particle imaging (MPI), stem cell tracking modalities, and novel oral iron supplementation approaches, was critically evaluated. When integrated with multimodal imaging platforms and personalized therapeutic regimens, these advancements would pave the way for IONPs to become transformative agents in next-generation precision medicine.