{"id":1001116,"date":"2026-09-08T08:04:02","date_gmt":"2026-09-08T12:04:02","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/ge-healthcare-aims-to-advance-a-new-era-in-theranostics-with-starguide-gx-4d-spect-ct-now-510k-pending-with-the-u-s-fda\/"},"modified":"2026-09-08T08:04:02","modified_gmt":"2026-09-08T12:04:02","slug":"ge-healthcare-aims-to-advance-a-new-era-in-theranostics-with-starguide-gx-4d-spect-ct-now-510k-pending-with-the-u-s-fda","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/ge-healthcare-aims-to-advance-a-new-era-in-theranostics-with-starguide-gx-4d-spect-ct-now-510k-pending-with-the-u-s-fda\/","title":{"rendered":"GE HealthCare aims to advance a new era in theranostics with StarGuide\u2122 GX 4D SPECT\/CT, now 510(k) pending with the U.S. FDA"},"content":{"rendered":"<p>        <!--.bwblockalignl { margin-left: 0px; margin-right: auto }\n.bwcellpmargin { margin-bottom: 0px; margin-top: 0px }\n.bwlistdisc { list-style-type: disc }\n.bwpadl0 { padding-left: 0px }\n.bwtablemarginb { margin-bottom: 10px }\n.bwvertalignt { vertical-align: top }body {font:normal small Arial,Helvetica,sans-serif;color:#000;background-color:#fff;padding:24px;margin:0;} a img {border:0;} h3 {font-size:medium;color:#000;margin:0 0 1em 0; text-align:center;}-->  <\/p>\n<p>\nGE HealthCare aims to advance a new era in theranostics with StarGuide\u2122 GX 4D SPECT\/CT, now 510(k) pending with the U.S. FDA<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nStarGuide\u2122 GX<sup>i<\/sup> 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<\/p>\n<\/li>\n<li>\nDesigned for the theranostics era, StarGuide GX incorporates a versatile, future-ready SPECT\/CT system capable of imaging across a broad spectrum of energy levels \u2013 including investigational alpha emitters \u2013 while delivering ultra-high sensitivity, high-resolution imaging and accurate quantitation to support precision care<\/p>\n<\/li>\n<li>\nEngineered 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<\/p>\n<\/li>\n<\/ul>\n<p>CHICAGO&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<br \/>\nGE HealthCare today announced that StarGuide GX,<sup>i<\/sup> 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\u2019s <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.gehealthcare.com%2Fen-us%2Fabout%2Fnewsroom%2Fpress-releases%2Fge-healthcare-announces-ce-mark-for-new-digital-4d-spectct-system-starguide-gx%3Fsrsltid%3DAfmBOorbghEcg7eThRov4J8oi80EaRsDpoA4Zf9DB38UbDTyld0YjULp&amp;esheet=54599462&amp;newsitemid=20260906477921&amp;lan=en-US&amp;anchor=recent+CE+Mark&amp;index=1&amp;md5=0996a62cde4287481a0dffd7e1e3a0c2\">recent CE Mark<\/a>, 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\u2019s evolution \u2013 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.<\/p>\n<p id=\"news-body-cta\">This press release features multimedia. View the full release here: <a href=\"https:\/\/www.businesswire.com\/news\/home\/20260906477921\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20260906477921\/en\/<\/a><\/p>\n<div id=\"bwbodyimg\" style=\"width: 480px;float:left;padding-left:0px;padding-right:20px;padding-top:0px;padding-bottom:0px\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20260906477921\/en\/2891803\/4\/StarGuide_GX.jpg\" alt=\"GE HealthCare&apos;s StarGuide GX\" \/><\/p>\n<p style=\"font-size:85%\">GE HealthCare&#8217;s StarGuide GX<\/p>\n<\/div>\n<p>\n\u201cWe 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,\u201d said Prof. Ken Herrmann, Chair, Department of Nuclear Medicine, University Hospital Essen. \u201cAs new tracers \u2013 including the anticipated development of alpha-emitting agents \u2013 expand what\u2019s 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.\u201d<\/p>\n<p>\nMomentum 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,<sup>ii<\/sup> offer the potential for greater precision by delivering high-energy radiation over short distances to help minimize damage to surrounding healthy tissue.<sup>iii<\/sup> As this pipeline expands, the ability to accurately image and quantify alpha emitters is anticipated to become increasingly important \u2013 not only to support therapy planning and dosimetry, but also to monitor treatment response and advance clinical research.<sup>iv<\/sup><\/p>\n<p>\nThis 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 \u2013 supporting both general-purpose SPECT imaging and investigational radioligand therapy isotopes \u2013 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.<\/p>\n<p>\n\u201cStarGuide GX reflects the future of nuclear medicine, where flexibility, speed and quantitative accuracy are essential,\u201d said Erez Levy, Executive Director, Molecular Imaging, GE HealthCare. \u201cIt 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.\u201d<\/p>\n<p>\nPowered by GE HealthCare\u2019s patented dual-sided cadmium zinc telluride (CZT) detector technology, StarGuide GX is designed to deliver double volume sensitivity<sup>v<\/sup> 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.<\/p>\n<p>\nAdditionally, the system\u2019s 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\u2019s automatic collimator exchange also aims to eliminate the need for multiple collimators and carts as well as the space required for storage.<\/p>\n<p>\n\u201cAt GE HealthCare, we are committed to bold, intentional innovation that anticipates where healthcare is going \u2013 and equips clinicians with the technology they need to get there,\u201d said Jean-Luc Procaccini, President and CEO, Molecular Imaging and Computed Tomography, GE HealthCare. \u201cWith 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.\u201d<\/p>\n<p>\nAs nuclear medicine continues to evolve \u2013 particularly with the rapid growth of theranostics \u2013 GE HealthCare remains committed to delivering innovative solutions that help clinicians and researchers push the boundaries of what is possible. The 510(k) pending status of StarGuide GX marks an important step in GE HealthCare\u2019s aim to bring this next-generation technology to U.S. healthcare providers.<\/p>\n<p>\nFor more information on GE HealthCare\u2019s molecular imaging portfolio, visit <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.gehealthcare.com%2Fen-us%2Fproducts%2Fmolecular-imaging&amp;esheet=54599462&amp;newsitemid=20260906477921&amp;lan=en-US&amp;anchor=gehealthcare.com&amp;index=2&amp;md5=6441bcfb25b30599d234354b11559332\">gehealthcare.com<\/a>.<\/p>\n<p><b>About GE HealthCare Technologies Inc.<\/b><\/p>\n<p>\nGE 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\u2019s 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.<\/p>\n<p>\nGE HealthCare is proud to be among <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Ffortune.com%2Franking%2Fworlds-most-admired-companies%2F&amp;esheet=54599462&amp;newsitemid=20260906477921&amp;lan=en-US&amp;anchor=2026+Fortune+World%26%238217%3Bs+Most+Admired+Companies%26%238482%3B.&amp;index=3&amp;md5=148979a4da187dab2c1b0e3fe9698cfe\">2026 <i>Fortune<\/i> World\u2019s Most Admired Companies\u2122.<\/a><\/p>\n<p>\nFollow us on <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fgehealthcare&amp;esheet=54599462&amp;newsitemid=20260906477921&amp;lan=en-US&amp;anchor=LinkedIn&amp;index=4&amp;md5=ee8722398813a8bd9349f1e67b73e568\">LinkedIn<\/a>, <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.facebook.com%2FGEHealthCare%2F&amp;esheet=54599462&amp;newsitemid=20260906477921&amp;lan=en-US&amp;anchor=Facebook&amp;index=5&amp;md5=a2a03846bd659e19dcd8b1d6fb1a402b\">Facebook<\/a>, <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.instagram.com%2Fgehealthcare%2F&amp;esheet=54599462&amp;newsitemid=20260906477921&amp;lan=en-US&amp;anchor=Instagram&amp;index=6&amp;md5=99b6a91a5e9200c15e967ac966cb531d\">Instagram<\/a>, or visit our website for our <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.gehealthcare.com%2Fen-us%2Fabout%2Fnewsroom&amp;esheet=54599462&amp;newsitemid=20260906477921&amp;lan=en-US&amp;anchor=latest+news&amp;index=7&amp;md5=f45309dd2b977fb784ccd51a7bfc2bfd\">latest news<\/a> and <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.gehealthcare.com%2Fen-us%2Finsights&amp;esheet=54599462&amp;newsitemid=20260906477921&amp;lan=en-US&amp;anchor=perspectives&amp;index=8&amp;md5=772dcf812ec2ab097017bbe36b9a6534\">perspectives<\/a>.<\/p>\n<table cellspacing=\"0\" class=\"bwtablemarginb bwblockalignl\">\n<tr>\n<td class=\"bwvertalignt bwpadl0\" colspan=\"2\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n___________________________________<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwpadl0\" colspan=\"2\" rowspan=\"1\">\n<p class=\"bwcellpmargin\"><sup>i<\/sup> 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.<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwpadl0\" colspan=\"2\" rowspan=\"1\">\n<p class=\"bwcellpmargin\"><sup>ii<\/sup> Targeted alpha therapy development and growing clinical interest: Journal of Nuclear Medicine Technology; ScienceDirect review on Actinium-225 applications.<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwpadl0\" colspan=\"2\" rowspan=\"1\">\n<p class=\"bwcellpmargin\"><sup>iii<\/sup> Innovation News Network, \u201cTRIUMF and Actinium-225: The world\u2019s rarest drug.\u201d<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwpadl0\" colspan=\"2\" rowspan=\"1\">\n<p class=\"bwcellpmargin\"><sup>iv<\/sup> Nature Scientific Reports; Wiley International Journal of Imaging Systems and Technology \u2013 imaging and dosimetry importance for alpha emitters.<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwpadl0\" colspan=\"2\" rowspan=\"1\">\n<p class=\"bwcellpmargin\"><sup>v<\/sup> 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.<\/p>\n<\/td>\n<\/tr>\n<\/table>\n<p>\n\u00a0<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20260906477921r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" style=\"width:0;height:0\" \/><span class=\"bwct31415\" \/><\/p>\n<p id=\"mmgallerylink\"><span id=\"mmgallerylink-phrase\">View source version on businesswire.com: <\/span><span id=\"mmgallerylink-link\"><a href=\"https:\/\/www.businesswire.com\/news\/home\/20260906477921\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20260906477921\/en\/<\/a><\/span><\/p>\n<p><b>GE HealthCare Media Contact:<br \/>\n<\/b><br \/>Margaret Steinhafel<br \/>\n<br \/>Global Communications Director, Molecular Imaging, Computed Tomography and X-ray<br \/>\n<br \/>M +1 608 381 8829<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:margaret.steinhafel@gehealthcare.com\">margaret.steinhafel@gehealthcare.com<\/a><\/p>\n<p><b>KEYWORDS:<\/b> Illinois United States North America<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Oncology Health FDA Health Technology Other Health General Health Radiology<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\">\n<tr>\n<td><font face=\"Arial\" size=\"2\"><b>Photo<\/b><\/font><\/td>\n<\/tr>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20260906477921\/en\/2891803\/3\/StarGuide_GX.jpg\" alt=\"Photo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\">GE HealthCare&#8217;s StarGuide GX<\/font><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><b>Logo<\/b><\/font><\/td>\n<\/tr>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20260906477921\/en\/1907724\/3\/GE_HealthCare_logo_NEW_March_2023.jpg\" alt=\"Logo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>GE HealthCare aims to advance a new era in theranostics with StarGuide\u2122 GX 4D SPECT\/CT, now 510(k) pending with the U.S. FDA StarGuide\u2122 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 \u2013 including investigational alpha emitters \u2013 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 &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/ge-healthcare-aims-to-advance-a-new-era-in-theranostics-with-starguide-gx-4d-spect-ct-now-510k-pending-with-the-u-s-fda\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;GE HealthCare aims to advance a new era in theranostics with StarGuide\u2122 GX 4D SPECT\/CT, now 510(k) pending with the U.S. FDA&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-1001116","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.4 - 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