GE医疗宣布五家国际机构临床评估下一代StarGuide GX数字SPECT/CT，但美国仍待510(k)、无订单金额

Leading institutions will evaluate StarGuide GX
i
across quantitative imaging, dynamic imaging and emerging theranostic applications
Clinical experience from more than 1,000 patient studies was established ahead of the
European Association of Nuclear Medicine
(EANM) 2026 Annual Meeting in
Vienna, Austria
Insights will help guide the future evolution of
GE HealthCare's
digital SPECT/CT platform and inform the next generation of nuclear medicine imaging
CHICAGO
&
VIENNA
--(BUSINESS WIRE)--Oct. 20, 2026--
GE HealthCare
(Nasdaq: GEHC) today announced a global clinical evaluation program spanning three continents and five internationally recognized institutions to assess StarGuide™ GX,
i
its next-generation digital 4D SPECT/CT system. Participating institutions include
Hadassah Medical Center
in
Israel
;
Mayo Clinic
in
the United States
; Oncopole Claudius Regaud – Institut Universitaire du Cancer de Toulouse in
France
;
Peking University First Hospital
in
China
; and Rambam Health Care Campus.
Across the program, participating institutions will evaluate image quality, quantitative performance, dynamic imaging and workflow while providing clinical and research feedback to help inform the future evolution of StarGuide GX.
“Nuclear medicine is entering a new era in which imaging is expected to do more than identify disease – it is increasingly being used to quantify biological processes, support treatment decisions and monitor response to therapy,” said
Erez Levy
, Executive Director, Molecular Imaging,
GE HealthCare
. “By working across multiple regions and care environments, we aim to generate clinical and research insights that can help inform innovation as imaging, quantitation and workflow needs evolve.”
Expanding quantitative and dynamic imaging capabilities
StarGuide GX uses dual-sided cadmium zinc telluride (dsCZT) detector technology and is designed to support high-sensitivity, high-resolution imaging, quantitative imaging and dynamic acquisitions. Its detector configuration allows the detectors to move close to the patient during imaging, while its patented dual-collimator detector design is intended to eliminate the need for manual external collimator exchanges and streamline imaging workflows.
Additionally, the system is engineered to support radionuclides across a broad energy range and, in research settings, it may also be evaluated for imaging radionuclides associated with emerging alpha-emitter research, including Actinium-225, focused on the potential to expand theranostic applications.
ii
“The technological innovations introduced by StarGuide GX are particularly exciting for the future of theranostics,” shared Prof. Frederic Courbon, Head of the
Imaging Department
, Oncopole Claudius Regaud – Institut Universitaire du Cancer de Toulouse. “The system's ergonomic design and flexibility have the potential to significantly improve workflow while supporting precision in quantitative imaging and high-energy radionuclide applications. Our first experience suggests that StarGuide GX represents a meaningful step forward in enabling advanced theranostic practices.”
StarGuide GX also uses NVIDIA RTX™ accelerated computing to support image reconstruction, and includes a Low-Medium Energy collimator that is designed to provide up to 2.67-times system volume sensitivity.
iii
Global collaborations advance nuclear medicine research
Five new, global clinical collaborations will evaluate the platform across diverse care settings:
iv
Hadassah Medical Center
(
Israel
): Evaluate advanced quantitative capabilities following the system’s recent field upgrade.
Mayo Clinic
(
United States
): Evaluate advanced quantitative and dynamic imaging applications.
Oncopole Claudius Regaud – Institut Universitaire du Cancer de Toulouse (
France
): Assess StarGuide GX, the department's general-purpose SPECT/CT platform, across routine oncology imaging and clinical research.
Peking University First Hospital
(
China
): Explore novel tracer research and preclinical applications.
Rambam Health Care Campus (
Israel
): Evaluate StarGuide GX imaging workflows through extensive clinical use across a broad range of nuclear medicine applications and tracers.
These new collaborations build on GE HealthCare’s work with
University Hospital Essen in
Germany
, which in
June 2026
opened a new state-of-the-art Nuclear Medicine Center featuring the world’s first installation of StarGuide GX SPECT/CT.
To date, these diverse healthcare institutions have scanned more than 1,000 patients.
StarGuide GX received
CE Mark
in
November 2025
and is available for sale in select European Union member states. The system is 510(k) pending with the
U.S
. FDA and is not currently available for sale in
the United States
.
For more information about GE HealthCare’s molecular imaging portfolio, visit
gehealthcare.com
or see the system in the company’s booth at the European Association of Nuclear Medicine’s 2026 Annual Meeting,
October 17-21
in
Vienna, Austria
.
About GE HealthCare Technologies Inc.
GE HealthCare is a leading global healthcare solutions provider of advanced medical technology, pharmaceutical diagnostics, and AI, cloud and software solutions that help clinicians tackle the world’s most complex diseases. Serving patients and providers for 130 years, GE HealthCare is delivering bold innovations designed for the next era of medicine across its Advanced Imaging Solutions, Pharmaceutical Diagnostics and Patient Care Solutions segments to help clinicians deliver more personalized, precise patient care. We are a $20.6 billion business with approximately 54,000 colleagues working to create a world where healthcare has no limits.
GE HealthCare is proud to be among
2026
Fortune
World’s Most Admired Companies™.
Follow us on
LinkedIn
,
Facebook
,
Instagram
, or visit our website for our
latest news
and
perspectives
.
StarGuide GX is CE marked and 510(k) pending with the U.S. FDA. Not available for sale in the United States.
Investigational tracers. Not approved by the U.S. FDA or any other regulatory authority for clinical use.
StarGuide GX with Low-Medium collimator has up to a 2.67-times increase in system volume sensitivity compared with NM/CT 870 DR with LEHRS collimator. System volume sensitivity measured per NEMA NU-1 2023, with adaptations for StarGuide GX.
The products and applications evaluated may be investigational, may not be commercially available in all markets and may be subject to applicable regulatory requirements. Evaluation activities and timelines vary by institution.
View source version on businesswire.com:
https://www.businesswire.com/news/home/20261020521542/en/
GE HealthCare Media Contact
Margaret Steinhafel
Global Communications Director, Molecular Imaging, Computed Tomography and X-ray
M +1 608 381 8829
margaret.steinhafel@gehealthcare.com
Source: GE HealthCare