Announcement • Sep 08

GE HealthCare Announces StarGuide GX 4D SPECT/CT 510(k) Pending With U.S. FDA

GE HealthCare had announced that StarGuide GX,i its new digital 4D CZT SPECT/CT technology, is 510(k) pending with the U.S. Food and Drug Administration (FDA). Building on the system’s recent CE Mark, this milestone is a step towards expanding access to advanced molecular imaging technologies in the United States and marks a significant moment in molecular imaging’s evolution – aiming to empower clinicians with a high-performance, general purpose scanner to help personalize care across a growing range of nuclear medicine applications and tracers, including the acquisition of alpha emitters. StarGuide GXi is 510(k) pending with the U.S. FDA following its recent CE Mark, marking continued momentum in bringing next-generation 4D CZT SPECT/CT innovation to clinicians and expanding access to advanced molecular imaging technologies. Designed for the theranostics era, StarGuide GX incorporates a versatile, future-ready SPECT/CT system capable of imaging across a broad spectrum of energy levels – including investigational alpha emitters – while delivering ultra-high sensitivity, high-resolution imaging and accurate quantitation to support precision care. Engineered to help nuclear medicine departments improve efficiency without compromising image quality, the system leverages novel dual-sided CZT detector technology to overcome traditional trade-offs between sensitivity and spatial resolution. Momentum is growing in nuclear medicine, driven by a developing pipeline of radioligand therapies poised to reshape the field. Increasing clinical and research interest in alpha-emitting isotopes, such as Actinium-225, Lead 212 and others for highly targeted cancer treatment, offer the potential for greater precision by delivering high-energy radiation over short distances to help minimize damage to surrounding healthy tissue. As this pipeline expands, the ability to accurately image and quantify alpha emitters is anticipated to become increasingly important – not only to support therapy planning and dosimetry, but also to monitor treatment response and advance clinical research. This shift highlights the potential value of imaging technologies like StarGuide GX, which is designed to deliver the sensitivity, flexibility, and energy range expected to be important for keeping pace with emerging tracers. Designed for versatility, the system can image across a broad spectrum of energy levels – supporting both general-purpose SPECT imaging and investigational radioligand therapy isotopes – aiming to enable clinicians and researchers to explore new diagnostic and therapeutic pathways while maintaining exceptional image clarity and quantitation critical for treatment planning and monitoring. Powered by GE HealthCare’s patented dual-sided cadmium zinc telluride (CZT) detector technology, StarGuide GX is designed to deliver double volume sensitivity and maintain high-resolution imaging, enabling clinicians to capture more information with shorter scan times. The system also incorporates NVIDIA RTX computing to help optimize image reconstruction and accelerate time to results. Additionally, the system’s patented dual-collimator detector is designed to enable collimator exchange in less than three seconds, aiming to streamline workflows by shortening traditional collimator exchange procedures. StarGuide GX’s automatic collimator exchange also aims to eliminate the need for multiple collimators and carts as well as the space required for storage. StarGuide GX is CE marked and 510(k) pending with the U.S. FDA. Available for sale in EU member states. Not approved or cleared by the U.S. FDA. Not available for sale in the United States and other non-EU member state countries. StarGuide GX with Low-Medium collimator has up to 2.67x increase in System Volume Sensitivity as compared to NM/CT 870 DR with LEHRS collimator. Measured per NEMA NU-1 2023.

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