GE HealthCare Files 510(k) for StarGuide GX 4D SPECT/CT

GE Healthcare revealed that its StarGuide GX digital 4D CZT SPECT/CT technology is 510(k) pending with the U.S. Food and Drug Administration (FDA).

Following the system’s recent CE mark, this milestone moves the company closer to expanding access to advanced molecular imaging in the U.S. The high-performance, general-purpose scanner is designed to support personalized care across a growing range of nuclear medicine applications and tracers, including alpha emitters.

StarGuide GX is designed to deliver the sensitivity, flexibility, and energy range needed to support emerging tracers. Its broad energy range enables both general-purpose SPECT imaging and investigational radioligand therapy isotopes, while maintaining image clarity and quantitative accuracy for treatment planning and monitoring.

Powered by GE HealthCare’s dual-sided cadmium zinc telluride (CZT) detector technology, StarGuide GX is designed to deliver double-volume sensitivity and high-resolution imaging, enabling shorter scans and greater data capture. NVIDIA RTX computing accelerates image reconstruction and time to results.

Its dual-collimator detector enables collimator exchange in less than three seconds, streamlining workflows while reducing the need for multiple collimators, carts, and storage space.

Comments from GE HealthCare and clinicians

Erez Levy, Executive Director, Molecular Imaging: “StarGuide GX reflects the future of nuclear medicine, where flexibility, speed, and quantitative accuracy are essential. It is designed to act as an all-in-one system and support advanced imaging techniques and emerging tracers, aiming to provide a powerful tool for clinicians looking to expand clinical capabilities and deliver personalized care.”

Jean-Luc Procaccini, President & CEO, Molecular Imaging & Computed Tomography: “At GE HealthCare, we are committed to bold, intentional innovation that anticipates where healthcare is going – and equips clinicians with the technology they need to get there. With StarGuide GX now 510(k) pending in the U.S. and CE Marked in Europe, we are advancing a new generation of molecular imaging technologies designed to support the growth of theranostics and precision care, aiming to help clinicians confidently adopt new and evolving tracers, expand clinical practice and deliver more personalized care to every patient.”

Prof. Ken Herrmann, Chair, Department of Nuclear Medicine, University Hospital Essen: “We are seeing a meaningful evolution in precision care, driven in large part by the continued growth of theranostics and the integration of imaging and targeted therapies. As new tracers—including the anticipated development of alpha-emitting agents—expand what’s possible in diagnosis and treatment, it is essential that imaging technology evolves alongside them. Having systems that can accurately capture, quantify and support these advances will be critical to enabling more personalized care and improving patient outcomes.”