GE HealthCare is showcasing its latest molecular imaging technologies for cardiology—including Flyrcado (flurpiridaz F 18)—at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting in New Orleans. The company’s portfolio, which includes imaging systems, radiopharmaceuticals, and analysis software, is aimed at improving the diagnosis and monitoring of cardiovascular disease (CVD), including coronary artery disease (CAD).

Central to this effort is GE HealthCare’s Flyrcado (flurpiridaz F 18) injection, a PET myocardial perfusion imaging (MPI) agent developed for use in patients with known or suspected CAD. Approved for use in the US, Flyrcado provides clinicians with a new option for cardiac PET imaging, offering higher diagnostic efficacy than SPECT MPI—the more commonly used modality in nuclear cardiology today.

“Flyrcado represents one of the most significant advancements in nuclear cardiology in decades,” says Marcelo Fernando DiCarli, MD, chief of the Division of Nuclear Medicine and Molecular Imaging, Department of Radiology and Executive Director, Cardiovascular Imaging Program, Departments of Radiology and Medicine, Brigham and Women’s Hospital, in a release. “For the first time in nearly 20 years, we have a new PET myocardial perfusion tracer that brings latest imaging technology within reach for patients across the US. The image quality is exceptional, and its use has the potential to reduce unnecessary invasive procedures by improving diagnostic confidence.”

Coverage Expands for Flyrcado F 18

Flyrcado was recently launched in select US markets. As of April 1, the agent received CMS pass-through status and a specific HCPCS billing code. GE HealthCare reports that it is now covered by all seven Medicare Administrative Contractors and included in updated commercial cardiac PET coverage policies affecting more than half of the US commercially insured population. Additional policy updates are expected later in the year. The company has also introduced a Flyrcado Support Center to assist with benefits investigation, coding, and claims submissions.

Flyrcado is compatible with multiple PET/CT systems, including Omni Legend, which GE HealthCare says supports flexible cardiac PET workflows. The system is designed to accommodate a range of tracers and is part of a scalable platform developed to meet demands for shorter scan times and lower radiation doses.

“With coverage now in place for all traditional Medicare beneficiaries, along with updated PET coverage policies in place for more than half of the nation’s commercially insured beneficiaries, millions of Americans—many at risk for or living with coronary artery disease, the leading cause of death in the US—will have greater access to this innovative technology,” says Eric Ruedinger, vice president and general manager of GE HealthCare’s pharmaceutical diagnostics division for the US and Canada, in a release. 

SPECT/CT and Software Spotlighted

Additional cardiac imaging technologies on display include:

• StarGuide and Aurora: SPECT/CT systems designed to support cardiac diagnostics by capturing gamma rays from injected tracers. Both systems are optimized for image quality and scan efficiency, allowing clinicians to assess both physiological and structural cardiac conditions.
• MIM Software: Provides tools for multimodality image viewing, cardiac image fusion, and integration pathways for analysis across platforms.

These technologies aim to support early diagnosis, risk stratification, treatment planning, and monitoring in cardiology. According to GE HealthCare, molecular imaging—including PET and SPECT—offers detailed insights into biological processes, helping clinicians tailor treatment strategies and assess therapy response.

Photo caption: Flyrcado (flurpiridaz F 18)

Photo credit: GE HealthCare

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At the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, GE HealthCare is highlighting new technologies designed to support precision care in theranostics and molecular imaging. 

The company’s latest innovations include AI-powered software for tumor burden analysis, new imaging systems, and radiopharmaceutical tools intended to streamline workflows and support personalized treatment planning.

“Every day counts when it comes to cancer care. The latest theranostics solutions will help our care teams more quickly and easily keep tabs on patient readiness and reduce patient coordination time—freeing up more time for clinicians to focus on direct patient care,” says Erik Mittra, MD, PhD, professor of diagnostic radiology in the at Oregon Health & Science University, in a release.

Among the new releases is LesionID Pro, a version of GE HealthCare’s MIM Software featuring automated, zero-click pre-processing. The tool is designed to help physicians reduce time spent on manual lesion segmentation and image registration when analyzing whole-body tumor burden. According to GE HealthCare, the software improvements aim to support therapy response monitoring and more efficient reporting.

Molecular imaging—such as positron emission tomography (PET) and single photon emission computed tomography (SPECT)—plays a central role in theranostics by helping clinicians monitor disease and guide treatment. GE HealthCare’s updates to LesionID Pro aim to address common challenges in this space, including time-consuming manual processes. The latest version includes algorithm improvements that provide whole-body tumor volume data, which physicians can review and finalize using newly designed tools.

Theranostics-Enabling Solutions on Display

Also on display at SNMMI, as part of GE HealthCare’s portfolio of theranostics-enabling solutions, are the following innovations:

• MINItrace Magni: GE HealthCare’s newest cyclotron technology, designed with a small footprint (about the size of a commercial refrigerator) and the goal of providing an easy-to-site, easy-to-install solution for the reliable, in-house production of commercial PET tracers and radiometals, including Gallium-68, used in diagnostic imaging to support personalized care plans.
• Omni Legend: A PET/CT system designed to reduce dose by up to 40% while maintaining image quality. The system is intended to support growing demand for high-performance PET/CT in theranostic applications.
• StarGuide: A digital SPECT/CT system with 12 CZT detectors that offers 3D imaging and short scan times. The design supports lesion detection, therapy monitoring, and high patient throughput.
• Aurora: A dual-head SPECT/CT system featuring a 40 mm CT detector and dose reduction capabilities. The system is designed to provide image quality and operational efficiency in hybrid imaging environments.
• Theranostics Pathway Manager Tile: An application available through GE HealthCare’s Command Center software. The tool is designed to help clinical teams coordinate the theranostics care pathway by tracking patient readiness for therapy and consolidating information from multiple sources. Oregon Health & Science University will be an early adopter.

“Precision care is the future of oncology—and theranostics is at the heart of that future. The integration of advanced imaging and AI-powered software is accelerating the adoption of theranostics in clinical practice,” says Shyam Srinivas, MD, PhD, chief of nuclear medicine, associate clinical professor, Department of Radiological Sciences, University of California, Irvine, in a release. “With tools like GE HealthCare’s Omni Legend, StarGuide, and MIM software at our disposal, we now have the ability to visualize disease with great clarity, quantify tumor burden efficiently, and make fast, informed decisions.”

Photo caption: LesionID Pro

Photo credit: GE HealthCare

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SHINE Technologies, a nuclear fusion company with a platform of medical isotope products, announced it has entered into a definitive agreement to acquire the SPECT business from Lantheus, a radiopharmaceutical-focused company. 

The acquisition will include the portion of the North Billerica, Massachusetts, campus that manufactures Lantheus’ SPECT products. By combining SHINE’s fusion-based isotope manufacturing technology with Lantheus’ established market channels, the transaction aims to strengthen SHINE’s leadership in the nuclear medicine market.

“Our companies have a long history of partnership, and we have admired Lantheus’ commitment to ensuring patient access to essential medical radioisotopes. By integrating Lantheus’ SPECT business and talented team with our company, we will expand our product portfolio, accelerate our path to market for our planned suite of isotopes and increase our market share—ultimately ensuring greater access to these life-saving products for patients,” says Greg Piefer, founder and CEO of SHINE, in a release.

Expanding Isotope Production Capabilities

For nearly 70 years, Lantheus has provided the nuclear medicine market with diagnostic radiopharmaceutical products. The company is a market leader in US production of technetium-99 (Tc-99), a medical isotope used in nuclear medicine imaging procedures. Lantheus’ SPECT product portfolio includes imaging agents for the heart, lung, thyroid, bladder, and more.

Chrysalis, SHINE’s large-scale irradiation facility, is set to become the largest isotope production facility in the world. Once operational, Chrysalis will complement the existing supply chain, ensuring a sustainable and reliable source of isotopes, including Mo-99, the world’s most widely-used isotope, and Lu-177, the most widely cancer cancer-fighting isotope.

Last year, SHINE opened one of the largest facilities in the western hemisphere dedicated to producing non-carrier-added lutetium-177. The facility has a production capacity of up to 100,000 doses of Lu-177 per year, with the ability to further expand to 200,000 doses per year.

“We are confident that SHINE’s expertise in isotope production as well as their commitment to growth and patient access position them well to continue our legacy with the SPECT business as we focus on advancing and expanding our pipeline of innovative diagnostics and therapeutics,” says Brian Markison, CEO of Lantheus, in a release. “SHINE’s interest in our SPECT business underscores the dedication and knowledge of our employees who have been instrumental to its decades-long success at Lantheus, and we thank our talented team for their contributions.” 

Photo caption: Chrysalis, SHINE’s large-scale irradiation facility

Photo credit: SHINE Technologies

GE HealthCare announced that the US Food and Drug Administration (FDA) granted 510(k) clearance of Aurora, a new dual-head SPECT/CT system, and Clarify DL, its AI-powered deep-learning image reconstruction technology. 

Aurora is designed to provide imaging precision, streamline workflows, and enable an improved patient experience. Its 40 mm detector—twice the detector coverage compared to CTs of other hybrid systems—and 128-slice plus intelligent imaging capabilities help support a range of clinical applications, from cardiology to oncology and neurology. Furthermore, Aurora’s available 5/8-inch crystal NaI detectors make it a suitable system for a range of clinical radiopharmaceuticals, including those used in the field of theranostics, according to a release from the company. 

Designed to build on this performance, Clarify DL offers image quality without having to increase injected dose or scan time. Leveraging deep learning technology, Clarify DL works to enhance bone SPECT image quality performance with clear, accurate, and effortless imaging, according to a release from GE HealthCare. In a clinical evaluation, Clarify DL’s image resolution was rated as better in 98% of the exams. Unlike traditional noise reduction techniques that may compromise contrast and resolution, Clarify DL is designed to optimize reconstruction without sacrificing image quality. 

[RELATED: GE HealthCare Unveils New CT System to Support Growing Demand for Cardiac Scans]

Additionally, Aurora is equipped with “effortless workflow” solutions to help ease technologists’ work from pre-scan to post-scan with various automation and design innovations, as well as help enhance patient comfort, including those with high BMI. 

“Aurora and Clarify DL are powerful reflections of GE HealthCare’s ongoing investment in next-generation imaging solutions that empower clinicians to practice precision medicine and make more informed decisions,” says Jean-Luc Procaccini, president and CEO of molecular imaging and computed tomography at GE HealthCare, in a release. “By providing diagnostic precision while enabling improved workflow, these nuclear medicine technologies allow clinicians to deliver effective, patient-centered care—ultimately helping drive better outcomes.” 

University Hospitals in Cleveland, Ohio, has become the first healthcare system in the United States to install this technology.  

“We are thrilled to be the first in the United States to adopt this incredibly impressive technology,” says Donna Plecha, MD, chair of the department of radiology, radiologist-in-chief, and Ida and Irwin Haber and Wei-Shen Chin, MD Chair in Radiology at University Hospitals, in a release. “Aurora’s seamless integration of SPECT and CT components will allow us to perform comprehensive, high-quality diagnostic exams in a single session, while its support of Clarify DL deep-learning image reconstruction enables enhanced image quality performance.” 

Photo caption: Aurora system

Photo credit: GE HealthCare

The scanner’s Optiso Ultra Dynamic Range (UDR) detector technology contains silicon photomultipliers (SiPMs), which enable the use of small 3.2 mm x 3.2 mm lutetium oxyorthosilicate (LSO) crystal elements. These tiny crystals provide higher spatial resolution than larger crystals. Leveraging these very small LSO crystals that are 100% covered by SiPMs, the Biograph Vision.X delivers 48-mm volumetric resolution and a temporal resolution of 178 ps.

For these reasons, the scanner can deliver a 20% performance improvement (TOF gain) that can improve patient throughput as well as reduce patient radiation exposure and radiotracer cost, according to Siemens.

“The Biograph Vision.X’s record-shattering, ultrafast time of flight delivers an image resolution that allows even the smallest lesions to rise above the noise,” says James Williams, PhD, head of Siemens Healthineers Molecular Imaging. “This extremely high level of resolution can help physicians detect small lesions and provide patients with a precise diagnosis.”

The built-in AIDAN imaging platform of the Biograph Vision.X uses artificial intelligence (AI) to increase operational efficiency and accelerate patient workflow. Its unique methodology is built on over 700 machine- and deep-learning patents from Siemens Healthineers.

Moreover, FlowMotion AI, a feature of AIDAN that is optional on the Biograph Vision.X, combines the continuous bed motion of Siemens Healthineers PET/CT scanners with anatomical AI to enable the user to standardize and personalize image acquisitions with one click.

The scanner’s large 78-cm bore helps calm anxious patients and allows easier positioning of bariatric patients or radiotherapy devices. It fits into any room that houses a PET/CT scanner from the Biograph Vision family.

The Biograph Vision.X is available as an in-field upgrade to current users of the Biograph Vision.

The Biograph Vision.X incorporates Optiso Ultra Dynamic Range (UDR) detector technology, which utilizes silicon photomultipliers (SiPMs). This offering allows for the use of small lutetium oxyorthosilicate (LSO) crystal elements measuring only 3.2 mm x 3.2 mm. The utilization of these tiny LSO crystals, fully covered by SiPMs, results in advanced spatial resolution. 

Moreover, the scanner achieves a 48-mm volumetric resolution and a temporal resolution of 178 ps.  Siemens officials say that, consequently, the Biograph Vision.X offers a 20% performance improvement (TOF gain), enhancing patient throughput while reducing radiation exposure and radiotracer costs.

James Williams, PhD, head of Siemens Healthineers Molecular Imaging, spoke out about this feature, commenting: “The Biograph Vision.X PET/CT scanner builds on the success of our Biograph Vision system and underscores our commitment to leading the industry in time of flight for improved lesion detection and enhanced anatomical detail. This improvement in TOF translates into increased sensitivity and better imaging performance.”

“Precision of this caliber is increasingly vital as PET/CT imaging is now employed by physicians throughout the entire patient care cycle, from diagnosis to therapy monitoring and post-therapy follow-up,” he adds. “Such precision is particularly invaluable in theranostics, where diagnostic and therapeutic capabilities are combined to aid in treating patients with recurrent prostate cancer.”

Additionally, the Biograph Vision.X incorporates the AIDAN imaging platform, leveraging artificial intelligence (AI) to streamline operations and expedite the diagnostic process. AIDAN’s methodology draws on more than 700 machine- and deep-learning patents developed by Siemens Healthineers. Finally, the Biograph Vision.X features a 78-cm bore and facilitates positioning for radiotherapy devices or bariatric patients. 

The agreement will see SQM increase supply of iodine raw material year-on-year and is part of GE Healthcare’s broader commitment and investment plan to enable the production of 30 million more patient doses of iodinated contrast media annually by 2025.

Growth in CT Procedures

The growing global prevalence of chronic disorders has driven significant growth in CT procedures, leading to increased global demand for iodinated contrast media, used to enhance visualization of organs, blood vessels and tissues across clinical care pathways. 

GE Healthcare is also investing in production capacity to help meet this growing demand, including a new $30 million manufacturing line at its Cork, Ireland, contrast media production facility, which opens this week.

“We expect global demand for iodinated contrast media to double in the next 10 years,” says Kevin O’Neill, president and CEO, GE Healthcare Pharmaceutical Diagnostics. “As an industry leader, we understand our responsibility to help meet this growing demand from customers and patients by investing in production capacity and securing higher volumes of iodine raw material.  As one of the largest consumers of iodine globally we value our longstanding relationship with SQM, an important partner for us.”

GE Healthcare Pharmaceutical Diagnostics develops and manufactures imaging agents used to support over 100 million procedures per year, equivalent to three patient procedures every second.

All stages of its contrast media manufacturing, from development of API to finished product, are managed entirely by GE Healthcare, adhering to current Good Manufacturing Practices (cGMP). With over 4,000 employees globally and seven manufacturing sites, the business also develops and supplies radiopharmaceuticals used to support diagnosis, monitoring and treatment selection across Neurology, Cardiology and Oncology clinical pathways.

“We’re pleased to continue our relationship with GE Healthcare–a key customer for us for more than 40 years,” says Pablo Altimiras, executive VP of Iodine and Nitrates, SQM. “As one of the largest producers of iodine worldwide with approximately 24 percent of our production used for X-ray contrast media, we are committed to the iodine industry and will continue to improve quality and increase capacity to ensure the reliability of supply, which is essential to so many sectors, including healthcare.” 

Historically, SPECT/CT has not been accessible to all healthcare providers. Instead, many institutions continue to use SPECT-only gamma cameras, which cannot always accommodate the clinical needs of a modern molecular imaging or radiology department. With its optimized, low-dose imaging and ability to fit into most existing SPECT rooms, the Symbia Pro.specta SPECT/CT system removes barriers to SPECT/CT adoption and helps providers transition from SPECT-only and early-generation SPECT/CT systems.

At the crux of the Symbia Pro.specta is myExam Companion, which includes a user interface that eliminates the traditional manual and user-dependent SPECT/CT imaging workflow. myExam Companion provides automated tools to guide the user through every step of the exam’s decision-making process—from system and patient preparation to image acquisition and reconstruction to evaluation and post-processing—so departments can achieve consistent results quickly and more easily, regardless of the patient, procedure, or user experience level. 

Another advancement that is standard is data-driven patient motion correction, which automatically corrects for patient movement in a SPECT exam with the click of a button, improving image quality without adding complexity. Additionally, data-driven respiratory motion correction for cardiac examinations is available as an option.

Designed for all SPECT/CT imaging applications, the Symbia Pro.specta can be tailored as needed with specialized clinical tools for optimized imaging in cardiology, neurology, oncology, orthopedics, and more. Flexible detectors along with an accessible design facilitate imaging for a range of patient types—including pediatric, obese, and physically challenged patients—without compromising exam quality, patient comfort, or staff efficiency. The scanner also can be used for either standalone diagnostic CT or SPECT imaging, providing the user with the same interface for simpler operation.

The Symbia Pro.specta features a minimum of 32 and a maximum of 64 CT slices, and it comes standard with a tin filter and CT iterative reconstruction for ultra-low patient and room dose. Its advanced quantification capabilities help the user determine the patient’s response to therapy. Capable of imaging at any energy level, the scanner is suitable for imaging the high-energy isotopes increasingly used in theranostics, an approach that combines diagnostic and therapeutic agents to treat patients.

“Siemens Healthineers is proud to introduce the Symbia Pro.specta SPECT/CT scanner, which provides our customers with the ideal vehicle for transitioning from their SPECT-only and first-generation SPECT/CT cameras to a state-of-the-art SPECT/CT scanner that can perform a full spectrum of nuclear medicine examinations,” says Jim Williams, PhD, head of molecular imaging at Siemens Healthineers . “The Symbia Pro.specta will help healthcare institutions overcome barriers to care by ensuring accessibility through its ease of use and ability to fit into existing SPECT rooms.”

AiCE was trained using vast amounts of high-quality data and features a deep learning neural network that can reduce noise and boost signal to quickly deliver, clear and distinct images, further opening doors for advancements in molecular imaging. A new approach to reconstruction, AiCE on the Cartesion Prime Digital PET/CT can provide fast exams at a lower dose with better image quality than traditionally acquired during both the PET and CT acquisitions.

“We’re taking innovation in molecular imaging one step further than ever thought possible with the availability of DLR on a digital PET/CT system. Having AiCE provide improved image quality and faster scans at a lower dose for both PET and CT acquisitions will be critically important for clinicians to chart the right course for their patients’ care,” says Tim Nicholson, managing director, Molecular Imaging Business Unit, Canon Medical Systems USA, Inc.

Nicholson adds, “As Canon Medical continues its expansion of AiCE into more modalities, it opens doors for more clinical applications to be made available for clinicians to ultimately help them provide even better patient care than ever before.”

Bacteria are good at mutating to become resistant to antibiotics. As one way to combat the problem of antimicrobial resistance, the Centers for Disease Control and Prevention (CDC) has called for the development of novel diagnostics to detect and help manage the treatment of infectious diseases.

“We really lack tools in the clinic to be able to visualize bacterial infections,” said Sanjiv Sam Gambhir, MD, PhD, chair of the radiology department and director of Precision Health and Integrated Diagnostics at Stanford University in California. “What we need is something that bacteria eat, that your cells—so-called mammalian cells—do not. As it turns out, there is such an agent, and that agent is maltose, which is taken up only by bacteria because they have a transporter, called a maltodextrine transporter, on their cell wall that is able to take up maltose and small derivatives of maltose.”

The traditional way of diagnosing bacterial infection involves biopsy of the infected tissue and/or blood and culture tests. Gambhir and colleagues developed a new positron emission tomography (PET) tracer, 6?-¹⁸F-fluoromaltotriose, that offers a non-invasive means of detection. The agent is a derivative of maltose and is labeled with radioactive fluorine-18 (¹⁸F). For this study, the tracer was evaluated in several clinically-relevant bacterial strains in cultures and in mouse models using a micro-PET/CT scanner. Its use to help monitor antibiotic therapies was also evaluated in rats.

Figure: Evaluation of 6”-18F-fluoromaltotriose in P. aeruginosa wound infection model. A) Bioluminescence images of CD1 mice bearing aeruginosa-infected wound (left panel) and control mice (right panel) B) Sagittal slices from micro PET/CT scan of the same mice 1 hour after intravenous administration of 6”-18F-fluoromaltotriose. Credit: Courtesy of Sam Gambhir, MD, PhD, Stanford University.

The results show that 6?-¹⁸F-fluoromaltotriose was taken up in both gram-positive and gram-negative bacterial strains, and it was able to detect Pseudomonas aeruginosa in a clinically relevant mouse model of wound infection.

Gambhir points out, “This is the first time this particular maltotriose, labeled with fluorine-18, has been synthesized and used in animal models. It’s able to pick up bacteria that may be present anywhere throughout your body, and it does not lead to an imaging signal from a site of infection that does not involve bacteria.”

He notes that the new agent even identified an infection in the heart of an animal. “We could pick up very small bacterial foci in a heart valve. And then when those animals were treated with an antibiotic, we could see that the signal went away in the heart. So, the properties of the tracer of sensitivity, specificity, low background signal throughout the animal are now facilitating its translation into humans.”

The results of this pre-clinical study demonstrate that 6?-¹⁸F-fluoromaltotriose is a promising new tracer for diagnosing most bacterial infections and has the potential to change the clinical management of patients suffering from infectious diseases of bacterial origin.

Looking ahead, Gambhir says, “The hope is that in the future when someone has a potential infection, this approach of injecting the patient with fluoromaltotriose and imaging them in a PET scanner will allow localization of the signal and, therefore, the bacteria. And then, as one treats them, one can verify that the treatment is actually working—so that if it’s not working, one can quickly change to a different treatment (for example, a different antibiotic). These kinds of findings are very important for patients, because they will very likely lead to entirely new ways to manage patients with bacterial infections, no matter where those infections might be hiding in the body.”

* The article, “Specific Imaging of Bacterial Infection Using 6?-¹⁸F-Fluoromaltotriose: A Second-Generation PET Tracer Targeting the Maltodextrin Transporter in Bacteria,” can be found on The Journal of Nuclear Medicine website here.