CHICAGO — September 8, 2026
GE HealthCare announced that its new StarGuide GX digital 4D CZT SPECT/CT system is now 510(k) pending with the U.S. Food and Drug Administration (FDA), marking another regulatory milestone for the company’s next-generation molecular imaging portfolio. The submission follows the system’s recent CE Mark in Europe and represents GE HealthCare’s continued effort to expand access to advanced imaging technologies designed for the rapidly developing theranostics market. StarGuide GX is being developed as a versatile, general-purpose SPECT/CT platform capable of supporting a broad range of nuclear medicine applications and tracers, including investigational alpha emitters. The regulatory progress highlights GE HealthCare’s strategy of preparing molecular imaging infrastructure for the growing convergence of diagnostic imaging and targeted radioligand therapies, while positioning StarGuide GX as a future-ready technology for clinicians and researchers. The system is designed to provide high sensitivity, high-resolution imaging and quantitative capabilities intended to support increasingly personalized approaches to diagnosis, treatment planning and response monitoring.
StarGuide GX Designed for the Expanding Theranostics Era
GE HealthCare is positioning StarGuide GX around the changing requirements of theranostics, where molecular imaging is increasingly used alongside targeted radioligand therapies to identify disease, select patients and monitor treatment. The company highlighted growing interest in emerging alpha-emitting isotopes, including Actinium-225 and Lead-212, as the radiopharmaceutical development pipeline expands. StarGuide GX is designed to image across a broad spectrum of energy levels, giving nuclear medicine departments a platform intended to accommodate both established SPECT applications and emerging investigational tracers. This flexibility is particularly relevant as healthcare providers and researchers explore new approaches to targeted cancer treatment and seek imaging systems capable of supporting evolving radiopharmaceutical workflows. GE HealthCare said the system is designed to provide the sensitivity, energy flexibility and quantitative accuracy needed to support advanced molecular imaging, including applications involving investigational alpha emitters. By focusing on a broad and future-ready imaging architecture rather than a single tracer or indication, the company is seeking to help nuclear medicine departments adapt their imaging capabilities as theranostics continues to develop.
Dual-Sided CZT Technology Targets Imaging and Workflow Efficiency
StarGuide GX incorporates GE HealthCare’s patented dual-sided cadmium zinc telluride (CZT) detector technology, which is designed to address traditional trade-offs between sensitivity and spatial resolution. According to the company, the system can provide up to 2.67x higher system volume sensitivity compared with the NM/CT 870 DR using its specified low-energy high-resolution collimator configuration, based on NEMA NU-1 2023 measurements. The architecture is intended to enable clinicians to capture more information while supporting shorter scan times without compromising image quality. StarGuide GX also integrates NVIDIA RTX computing to support image reconstruction and accelerate time to results. Another key workflow feature is its patented dual-collimator detector, which is designed to enable automatic collimator exchange in less than three seconds. GE HealthCare said this approach can reduce the need for multiple collimators and storage carts, potentially helping nuclear medicine departments simplify equipment management and improve operational efficiency. These engineering features form a central part of the company’s value proposition as healthcare providers seek higher-performing imaging systems while managing workflow and space constraints.
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GE HealthCare Builds Molecular Imaging Infrastructure for Theranostic
The StarGuide GX regulatory milestone strengthens GE HealthCare’s broader molecular imaging strategy as the company prepares for continued growth in theranostics and precision medicine. With the system now CE Marked in Europe and 510(k) pending in the United States, GE HealthCare is advancing its effort to bring a new generation of digital 4D SPECT/CT technology to healthcare providers. The company’s strategy centers on giving nuclear medicine departments greater flexibility to support established clinical applications while preparing for emerging tracers and radioligand therapies. The U.S. regulatory submission is an important step toward potential market access, although StarGuide GX is not currently FDA cleared or approved and is not available for sale in the United States. GE HealthCare continues to position molecular imaging as an important component of the expanding precision-care ecosystem, where quantitative imaging, advanced reconstruction and tracer flexibility can support increasingly sophisticated clinical workflows. By combining 4D CZT detector technology, rapid collimator exchange, advanced computing and broad energy-range imaging capabilities, GE HealthCare is positioning StarGuide GX as a future-oriented SPECT/CT platform designed to support the next phase of theranostics adoption
Source: GE HealthCare press release
