Author: Devanarayan, Viswanath ; Reyderman, Larisa ; Kramer, Lynn D ; Charil, Arnaud ; Irizarry, Michael C ; Reilhac, Anthonin ; Dhadda, Shobha ; Nelson, Todd M

BACKGROUND:

The visual interpretation of amyloid PET scans, or visual read (VR), is the most common technique used in clinical practice to identify the presence of cerebral amyloid plaques. Amyloid status (positive or negative) determined by VR or using a Centiloid (CL) cut-off shows high overall concordance. However, discordant cases can occur where the VR is positive, but the CL is below the positivity cut-off, or vice versa.

OBJECTIVES:

The objective of this analysis was to evaluate the rate of discordance and explore potential causes, particularly the role of amyloid tracer uptake in the white matter (WM), when determining amyloid status using VR and CL in screening for the elenbecestat phase 3 studies in early Alzheimer's disease (AD).

DESIGN:

Amyloid PET scans using either Florbetapir (Amyvid™), Florbetaben (Neuraceq™) or Flutemetamol (Vizamyl™) from 3,232 participants (1507 VR- and 1725 VR+) with cognitive impairment screened for the elenbecestat phase 3 studies in early AD were visually interpreted at screening by trained neuroradiologists and quantified using CL values.

SETTING:

Academic and clinical centers INTERVENTION/MEASUREMENTS: Quantitatively, amyloid positivity was defined as CL > 32.21. The number of positive cortical regions was determined by counting the number of regions with a standardized uptake value ratio (SUVr) that exceeded 1.17. PET SUVr levels in the cerebral WM were measured using an eroded WM region of interest (ROI). Statistical tests were conducted to detect differences among the four concordance groups, defined by the relationship of VR and CL status (positive or negative). Additionally, tests examined the relationship between uptake in the WM and rates and type of discordance. Receiver operating characteristic (ROC) analysis and DeLong's test were also used to examine the effect of different tracers on the discordant rates.

RESULT:

Discordance was observed in 6.53% of cases (n=211), with VR+/CL- in 4.61% (n=149) and VR-/CL+ in 1.92% (n=62). VR+/CL- discordant cases had significantly fewer amyloid-positive cortical regions compared to both VR+/CL+ and VR-/CL+ cases. VR-/CL+ cases had a significantly higher WM uptake than VR-/CL- and VR+/CL- cases. Our findings revealed a relationship between WM uptake and rates and types of discordance. High WM uptake can erroneously lead to CL+, due to gray matter (GM) contamination from the WM, and VR- status, due to reduced contrast between WM and GM, resulting in VR-/CL+ cases. Conversely, low WM uptake can result in an underestimation of CL values, inaccurately classifying a scan as CL-, and at the same time, the increased contrast may result in a VR+, thereby increasing the occurrence of discordant VR+/CL- cases.

CONCLUSION:

Variations in WM uptake significantly contribute to discordances by introducing positive or negative bias in CL values and altering the GM to WM contrast, which forms the basis of the VR. Nevertheless, the rates of discordant cases are low and VR represents a robust and validated method to determine the presence of amyloid deposition. VR enables enrolling patients with amyloid beta pathology, as seen on amyloid PET scans, whereas CL scaling was developed to provide standardized units that more consistently characterize longitudinal amyloid‑β change. These findings reflect the complementary roles of VR and CL in amyloid PET evaluation, with implications for refining diagnostic accuracy and disease monitoring in AD clinical trials and practice.

01 Mar 2026·Journal of Nuclear Medicine Technology

Quantitative Amyloid Brain Imaging: A Literature Review of the Centiloid Scale in Alzheimer Disease Evaluation

Review

Author: York, Benjamin ; Doroudinia, Abtin ; Colletti, Patrick M

Amyloid PET has become a pivotal imaging biomarker for Alzheimer disease (AD), enabling in vivo detection and quantification of β-amyloid deposition. However, variability in quantitative measurements across tracers, scanners, and analysis methods has considerably limited direct comparison of amyloid burden between studies and centers. To address this issue, the Centiloid Project has been developed to provide a standardized quantitative scale for amyloid PET, harmonizing results across tracers and institutions. In this literature review, we aim to summarize current evidence on the development, validation, and clinical application of the Centiloid scale in amyloid PET imaging, emphasizing its methodologic foundations, tracer-specific conversions, and diagnostic thresholds. Methods: A literature review was conducted using PubMed, Scopus, and Embase databases from January 2015 through October 2025. Search terms included "amyloid PET," "Centiloid," "SUVR," and "Alzheimer disease." We reviewed articles with quantitative amyloid PET analyses and Centiloid conversion and studies which compared multiple tracers using MIMneuro software Centiloid calibration. Results: The Centiloid method demonstrates strong intertracer and interscanner harmonization when standardized to the ¹¹C-Pittsburgh compound B reference, with high correlation (r ² > 0.9) across ¹⁸F-labeled tracers, including florbetapir, flutemetamol, and florbetaben. Most articles identified a Centiloid threshold between 20 and 25 Centiloids as indicative of significant amyloid pathology. Implementation of the Centiloid framework improved comparability across clinical trials and longitudinal studies, facilitating integration into the AT(N) research framework. Conclusion: The Centiloid scale represents a critical advancement in quantitative amyloid PET imaging, providing a universal reference that enhances data reproducibility, cross-trial comparisons, and clinical decision-making. Continued work is needed to expand standardization for novel tracers and hybrid imaging systems, ensuring full clinical translation of this metric in dementia imaging.

01 Dec 2025·Alzheimers & Dementia

Longitudinal multicenter head‐to‐head harmonization of tau‐PET tracers

Article

Author: Masdeu, Joseph C. ; Rosa‐Neto, Pedro ; Pascoal, Tharick A ; Gordon, Brian A. ; Bauer‐Negrini, Guilherme ; Fortea, Juan ; Tudorascu, Dana L ; Ferreira, Pamela C.L. ; Lowe, Val J ; Baker, Suzanne L. ; Karikari, Thomas K ; soleimani‐Meigooni, David N. ; Cehula, Juli ; Povala, Guilherme ; Pascual, Belen ; Oh, Hwamee ; Amaral, Livia ; Lussier, Firoza Z ; Bellaver, Bruna

Abstract:

Background:

Standardizing tau pathology quantification in vivo is challenged by inherent characteristics of tau‐PET tracers. The HEAD study aims to generate a leading, longitudinal head‐to‐head dataset of MK‐6240, Flortaucipir, RO948, and PI‐2620 tau‐PET to harmonize tracers' outcomes and develop tools to generalize findings across studies and trials. Here, we provide an update on the progression of the HEAD study.

Method:

HEAD is a multicentric study comprising nine performance sites. Recruitment aimed for 620 individuals between 18‐28 or 50‐90 years, classified as Young/CU/MCI/Dementia. The HEAD protocol involves clinical assessment utilizing the NACC Uniform Data Set, blood collection for banking of plasma/serum/buffy coat/whole blood, and MRI acquisition based on ADNI4. All participants undergo amyloid‐PET with either PiB/NAV4694/Florbetaben/Flutemetamol. All undergo head‐to‐head tau‐PET with at least two tracers, including MK‐6240 (90‐110), Flortaucipir (80‐100), PI‐2620 (45‐75), and RO948 (70‐90). PET data is reconstructed and processed uniformly similarly to ADNI4. The Laboratory of Neuroimaging (LONI) provides centralized databasing, and the National Centralized Repository for ADRD (NCRAD) provides the blood biorepository for all samples. All study procedures are repeated at 18 months.

Result:

Over 26 months, N = 679 participants were enrolled into HEAD, exceeding our proposed enrollment by 9.5%. Mean age of older adults is 72.1 years, female distribution is 54%, and 24% of individuals are from underrepresented groups (race/ethnicity/rurality). Progression in data collection has led to N = 551 (81%) of enrolled participants having a completed initial timepoint, and 1,489 total acquired head‐to‐head tau‐PET scans (mean acquisition window=34.9 days). Clinical characteristics including group distribution, APOEε4 carriership, plasma biomarker distribution (Aβ42/40 ratio/NfL/GFAP/PTau217), consensus visual rating of amyloid‐PET, and Braak stage classification are summarized in Figure 1. Two representative cases (CU/AD) of head‐to‐head tau‐PET with four tau tracers are shown in Figure 2. Longitudinal data collection has been initiated in N = 95 participants. Figure 3. demonstrates two cases (CU/MCI) of 18‐month longitudinal head‐to‐head tau‐PET with MK‐6240 and Flortaucipir.

Conclusion:

The HEAD study cohort represents a continued effort in the optimization of AD imaging biomarkers. Cross‐sectional and longitudinal data collection in HEAD are ongoing, in addition to comprehensive plasma biomarker measurements. Generation of findings from HEAD cohort data will provide novel and crucial guidance on the use of tau‐PET tracers.

News (Medical) associated with Flutemetamol F-18

18 Aug 2026

·www.prnewswire.com

Cortechs.ai Announces FDA Clearance for NeuroQuant® PET: Advancing Molecular Imaging for Cognitive Impairment

COVINGTON, Ky., Aug. 18, 2026 /PRNewswire/ -- NeuroQuant ® PET has received FDA 510(k) clearance (K261916) for PET. NeuroQuant PET ® aids physicians in the evaluation of patient pathologies and the clinical interpretation of PET performed for the assessment of cognitive impairment and other neurological conditions. Continue Reading NeuroQuant ® PET by Cortechs.ai has received FDA 510(k) clearance (K261916) for PET. As molecular imaging plays an increasingly central role in the diagnosis and management of Alzheimer's disease and related neurodegenerative disorders, the demand for standardized, objective PET analysis continues to grow. NeuroQuant® PET is designed to deliver fully automated quantification, regional analysis, and structured reporting directly into routine clinical workflows. "Automated quantitative PET imaging represents the next frontier in precision and personalized medicine for Alzheimer's disease and related neurocognitive disorders. These new technological advancements are enabling the shift from phenotype-based assessment to a biological, biomarker-driven approach in assessing neurodegenerative disease. I am excited about the role NeuroQuant PET will play in shaping the future of how these conditions are understood and managed." said Dr. Ana Franceschi, M.D., Ph.D. The platform provides atlas-based quantification for amyloid PET tracers, generating standardized uptake value ratios (SUVRs) and structured reports to support consistent, data-driven interpretation. NeuroQuant® PET segments regions of interest and quantifies Centiloids for commonly used amyloid PET tracers flutemetamol, florbetaben, and florbetapir, enabling standardized comparison across tracers and imaging systems. Compatible with PET-CT, PET-MR, and PET-only workflows, NeuroQuant® PET features fully automated processing and PACS-ready outputs designed to integrate quantitative metrics into existing workflows. "NeuroQuant® PET reflects our commitment to advancing quantitative imaging in dementia care, giving clinicians objective, reproducible measurements they can trust, so patients get earlier answers and more confident treatment decisions" said Kyle Frye, CEO of Cortechs.ai. "With FDA 510(k)-clearance status, we look forward to expanding access to standardized PET quantification that supports precision medicine in Alzheimer's disease and related dementias." About Cortechs.ai Cortechs.ai is the leader in AI applications in radiology, leveraging advanced technologies in medical imaging to enhance disease screening and timely assessment, empowering healthcare providers to deliver better outcomes for patients. The company develops and markets innovative medical imaging solution software for assessing neurological disorders such as Alzheimer's disease, epilepsy, multiple sclerosis, brain trauma, tumors and prostate cancer, helping clinicians identify and monitor clinically significant cases. Cortechs.ai's industry-leading imaging solutions offer radiologists, oncologists, and urologists streamlined, cost-effective tools to assist in the assessment of brain and prostate health, including cancer evaluation. Visit  for additional insights and follow us on Twitter, LinkedIn, and Facebook. For more information, please contact: [email protected] +1 858 459 9700 SOURCE Cortechs.ai 21% more press release views with Request a Demo

01 Jun 2026

·www.businesswire.com

GE HealthCare Focuses on Expanding Access to Nuclear Medicine Through AI, Radiopharmaceutical and Imaging Innovations

Nuclear medicine is reaching an inflection point as advances in imaging, theranostics and radiopharmaceuticals help accelerate clinical adoption At #SNMMI26, GE HealthCare is showcasing solutions designed to expand access, streamline workflows and support precision care across care pathways CHICAGO--(BUSINESS WIRE)--As theranostics adoption acceleratesi and radiopharmaceutical demand grows,ii healthcare systems are under increasing pressure to scale nuclear medicine operations while improving diagnostic confidence and workflow efficiency. At the 2026 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, GE HealthCare showcases its latest technologies and AI-enabled workflows to help support precision care across care pathways. “This is an exciting moment for nuclear medicine because we are moving beyond simply detecting disease to truly understanding its biology and behavior,” says Dr. Munir Ghesani, MD. Nuclear medicine is undergoing rapid expansion as healthcare systems increase adoption of theranostics, broaden radiopharmaceutical access and invest in precision diagnostics and targeted therapies. This momentum is also evident in global nuclear medicine market projections, which anticipate growth from approximately $7.8 billion in 2024 to more than $30.7 billion by 2034.iii “Nuclear medicine is moving from early innovation to large-scale clinical implementation,” shares Jean-Luc Procaccini, President and CEO, Molecular Imaging and Computed Tomography (MICT), GE HealthCare. “Healthcare systems need technologies and workflows that help expand access, improve efficiency and support more confident clinical decision-making as theranostics adoption and precision care evolve.” Turning convergence into clinical reality Growing demand for precision diagnostics and targeted therapies is helping accelerate the evolution of nuclear medicine. Advances in radiopharmaceuticals and imaging technologies help clinicians diagnose disease, improve treatment planning and expand access to personalized care. As adoption increases, healthcare systems are also facing new operational challenges – including how to scale infrastructure, streamline workflows and expand patient access beyond traditional hospital settings.iv Rising prevalence of chronic diseases is further driving demand for timely and advanced diagnoses and targeted treatment approaches. Fortunately, new care delivery models are already taking shape across care pathways. These models are increasingly enabled by advances in radiopharmaceuticals that expand access to PET imaging and support more scalable, routine clinical use across care settings. Early examples of this shift are emerging to reach patients beyond traditional hospital environments: Cardiology : GE HealthCare’s Flyrcado™ (flurpiridaz F 18 injection) is helping expand access to PET myocardial perfusion imaging (MPI) through a ready-to-use, unit-dose model designed for routine clinical workflows. The company is also collaborating with channel partners to accelerate the adoption of cardiac PET MPI in community settings while mobile imaging models are extending access beyond traditional hospital environments, bringing precision PET imaging to sites that may not otherwise have access. Neurology : As demand for Alzheimer’s diagnostics grows, v GE HealthCare offers Vizamyl™ (flutemetamol F 18 injection) and quantitative tools such as MIMneuro™ to support more consistent amyloid PET interpretation and clinical decision-making. These technologies can help providers integrate amyloid imaging more efficiently into routine neurological care pathways. Oncology : Theranostics adoption is also accelerating, i causing healthcare systems to seek more standardized approaches to imaging, treatment planning and response assessment. GE HealthCare’s StarGuide SPECT/CT, Intelligent Radiation Therapy (iRT) and MIM portfolio are designed with these needs in mind – helping simplify whole-body tumor burden assessment, streamline workflows and support more consistent treatment planning across care settings. These capabilities also support GE HealthCare’s vision for Adaptive Theranostics™ – a connected, data-driven approach that integrates molecular imaging, quantitative analysis and multidisciplinary workflows to help tailor therapy decisions over time. These capabilities also support GE HealthCare’s vision for Adaptive Theranostics™ – a connected, data-driven approach that integrates molecular imaging, quantitative analysis and multidisciplinary workflows to help tailor therapy decisions over time. “This is an exciting moment for nuclear medicine because we are moving beyond simply detecting disease to truly understanding its biology and behavior,” says Dr. Munir Ghesani, MD, FACNM, FACR, FSNMMI, Chief Medical Officer at United Theranostics and System Chief of Nuclear Medicine at the Mount Sinai Health System in New York. “Technologies that combine advanced imaging, quantitative analysis and innovative radiopharmaceuticals are helping clinicians make more informed decisions earlier in the care pathway – ultimately improving how we diagnose, treat and monitor patients.” GE HealthCare’s nuclear medicine portfolio spans imaging systems, AI-enabled software and pharmaceutical diagnostics designed to help clinicians support the full patient journey — from detection and diagnosis through therapy planning and monitoring. Translating rapid innovation into real-world clinical impact At SNMMI 2026, GE HealthCare is highlighting key technologies and software designed to help healthcare systems scale precision imaging, theranostics and quantitative analysis across clinical and research settings: Advanced imaging technologies – MIM KineticID ™: vi Advanced 510(k)-pending software designed for dynamic PET imaging and kinetic modeling, enabling quantitative, time-based analysis of radiotracer behavior to support more informed clinical and research decisions. MIM LesionID™ Pro : Recently 510(k) cleared by the U.S. FDA , this AI-powered software automates whole-body tumor burden analysis, reducing the need for manual lesion segmentation, physiologic uptake removal, or multi-image registration while enabling fast access to quantitative insights. Omni Legend : GE HealthCare’s fastest-selling PET/CT platform, now with more than 500 installations worldwide. vii Its high-sensitivity design supports faster scans, viii improved image quality and enhanced lesion detectability. ix Omni Legend also includes Precision DL deep learning image processing. StarGuide : A digital SPECT/CT platform featuring 12 CZT detectors and optimized for certain theranostic procedures, enabling high-quality 3D imaging, short scan times and quantitation. MINItrace Magni : x A compact cyclotron solution designed to simplify onsite production of PET tracers and radiometals, including Gallium-68, helping expand radiopharmaceutical access and support more localized production and personalized care delivery. Radiopharmaceuticals and imaging agents – Flyrcado : A PET imaging agent that helps doctors evaluate myocardial ischemia and infarction in people with known or suspected coronary artery disease, including during exercise stress tests. DaTscan ™ (ioflupane I‑123 injection): A proven neurological diagnostic radiopharmaceutical – celebrating 25 years in the global market – to visualize striatal dopamine transporters assisting in the evaluation of patients with suspected Parkinsonian syndromes (PSs) and suspected dementia with Lewy bodies (DLB). Cerianna ™ (fluoroestradiol F 18 injection): A PET radiopharmaceutical used to detect estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer. Vizamyl : A PET imaging agent used to estimate amyloid beta neuritic plaque density in adults with cognitive impairment to support evaluation of Alzheimer’s disease and other causes of cognitive decline, and to help inform selection of patients for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products. Together, these imaging technologies and agents are designed to support more scalable, data-driven and personalized nuclear medicine workflows across care pathways. Preparing the ecosystem for the next decade of growth As nuclear medicine adoption continues to grow, healthcare systems are increasingly focused on the operational requirements needed to support broader clinical use – including infrastructure, workflow standardization, radiopharmaceutical access and scalable decision support. xi Quantification and advanced imaging analytics are expected to play an increasingly important role in this evolution, particularly in neurodegenerative disease and theranostics, where more standardized interpretation and longitudinal assessment may help advance consistency across sites and clinicians. One way GE HealthCare is aiming to advance this evolution is through Adaptive Theranostics – a model that combines molecular imaging, quantitative analytics and connected clinical workflows to help clinicians personalize radioligand therapy decisions across treatment cycles. By supporting more consistent quantification, longitudinal assessment and multidisciplinary collaboration, Adaptive Theranostics is designed to help healthcare systems scale precision care as theranostics adoption grows. “As molecular imaging continues to scale, success will depend on more than individual products – it requires building the ecosystem around them,” says Eric Ruedinger, Vice President and General Manager, Pharmaceutical Diagnostics (PDx), USCAN, GE HealthCare. “We’re focused on enabling that ecosystem end-to-end – from tracer development and manufacturing to expanding access, integrating workflows and advancing the tools that support confident, consistent decision-making – so precision care can move from promise to sustained, everyday practice.” SNMMI 2026 represents a pivotal moment for the field – where decades of innovation are converging with new care models and expanding access to redefine how nuclear medicine is delivered. As these capabilities continue to scale, nuclear medicine is increasingly positioned as a cornerstone of precision medicine – enabling clinicians to visualize the biology of disease, tailor therapies to individual patients and monitor treatment response. To learn more about GE HealthCare’s full suite of nuclear medicine solutions, please visit gehealthcare.com. 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, Patient Care Solutions, and Pharmaceutical Diagnostics 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. Important Safety Information Cerianna™ (fluoroestradiol F 18 injection) Indication and Usage: Cerianna is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer. Limitations of Use: Tissue biopsy should be used to confirm recurrence of breast cancer and to verify ER status by pathology. Cerianna is not useful for imaging other receptors such as HER2 or progesterone receptor (PR). Contraindications: None. Adverse Reactions: In Clinical Trials (n=1207) the most common adverse reactions seen occurred at a rate < 1% were injection-site pain and dysgeusia. To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800-654-0118 or the FDA at 800-FDA-1088 or www.fda.gov/medwatch. For full prescribing information, please visit: https://www.gehealthcare.com/-/jssmedia/GEHC/US/Files/Products/Nuclear-Imaging-Agents/Cerianna/cerianna-pi DaTscan™ (ioflupane I‑123 injection) Indication and Usage: DaTscan is indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with suspected Parkinsonian syndromes (PS) or suspected dementia with Lewy bodies (DLB). Contraindications: Known hypersensitivity to ioflupane I‑123 or its components. Adverse Reactions: In clinical trials, headache, nausea, vertigo, dry mouth, or dizziness were reported at a rate of 1% or less. In postmarketing experience, hypersensitivity reactions and injection-site pain have been reported. To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 800 654 0118 (option 2, then option 1) or the FDA at 800 FDA 1088 or www.fda.gov/medwatch. Prior to DaTscan administration, please read the full Prescribing Information for additional Important Safety Information. Flyrcado™ (flurpiridaz F 18 injection) Indication and Usage: Flyrcado is a radioactive diagnostic drug indicated for PET myocardial perfusion imaging (MPI) under rest or stress in adult patients with known or suspected coronary artery disease (CAD) to evaluate myocardial ischemia and infarction. [accessdata.fda.gov] Contraindications: None. Adverse Reactions: The most common adverse reactions occurring during FLYRCADO PET MPI under rest and stress (pharmacologic or exercise) (incidence ≥ 2%) are dyspnea, headache, angina pectoris, chest pain, fatigue, ST segment changes, flushing, nausea, abdominal pain, dizziness, and arrhythmia. To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800-654-0118 or the FDA at 800-FDA-1088 or www.fda.gov/medwatch. For full prescribing information, click here. For important safety information, please click here. Vizamyl™ (flutemetamol F 18 injection) Indication and Usage: VIZAMYL™ (flutemetamol F 18 injection) is indicated for positron-emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: evaluation of Alzheimer’s disease (AD) and other causes of cognitive decline; and selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products Contraindications: Known hypersensitivity to Vizamyl or any excipient, including polysorbate 80. Adverse Reactions: The most commonly reported adverse reactions in clinical trials were flushing (2%), increased blood pressure (2%), headache (1%), nausea and dizziness (1%). Post marketing experience included anaphylactic reactions. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a casual relationship to drug exposure. To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800-654-0118 or the FDA at 800-FDA-1088 or www.fda.gov/medwatch. For full prescribing information, please visit: https://www.gehealthcare.com/content/dam/gehc/global/products/molecular-imaging-agents/vizamyl/documents/er-clinical-product-pi-en.pdf May 2026 JB14025US i Ezhilarasan, E., Sabarees, G. & Premkumar, P.P. Radioligand theranostics in oncology: emerging trends in target design and radiochemical innovation. J Radioanal Nucl Chem (2026). https://link.springer.com/article/10.1007/s10967-026-10891-3. ii Research and Markets. Radiopharmaceuticals Market Report 2026. Dublin: Research and Markets, 2026. https://www.researchandmarkets.com/reports/5939063/radiopharmaceuticals-market-report. iii Global Market Insights. U.S. Nuclear Medicine Market Size & Share, 2025–2034. Published October 2025. Accessed May 4, 2026. https://www.gminsights.com/industry-analysis/us-nuclear-medicine-market. iv Global Market Insights. Nuclear Medicine Market Opportunity, Growth Drivers, Industry Trend Analysis, and Forecast 2025–2034. Published October 8, 2025. Accessed April 16, 2026. https://www.giiresearch.com/report/gmi1858986-nuclear-medicine-market-opportunity-growth-drivers.html?utm_source=chatgpt.com v Grand View Research. U.S. Alzheimer’s Disease Diagnostics Market Report, 2030. San Francisco: Grand View Research, 2025. https://www.grandviewresearch.com/industry-analysis/us-alzheimers-disease-diagnostics-market-report. vi MIM KineticID is 510(k)-pending with the U.S. FDA. Not CE Marked. Not available for sale in the United States, Europe, Canada, or any other region. vii GE HealthCare data on file. viii Up to 53% reduction of PET scan time on Omni Legend 32 cm compared to Discovery MI 25 cm, as demonstrated in phantom testing. ix Omni Legend 32 cm increases small lesion detectability 16% on average and up to 20%, as compared to Discovery MI 25 cm with matched scan time/injected dose, as demonstrated in phantom testing using a model observer with 4 mm lesions; average of different reconstruction methods. x MINItrace Magni is technology in development. Not CE marked. xi Global Market Insights. Nuclear Medicine Market Opportunity, Growth Drivers, Industry Trend Analysis, and Forecast 2025–2034. Published October 8, 2025. Accessed April 16, 2026. https://www.giiresearch.com/report/gmi1858986-nuclear-medicine-market-opportunity-growth-drivers.html?utm_source=chatgpt.com

30 Sep 2025

·www.einpresswire.com

April - June 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Acetaminophen-containing products Anaphylactic reaction FDA is evaluating the need for regulatory action. Aptryxol (desvenlafaxine) DaTscan (ioflupane I 123 injection) Desvenlafaxine extended-release tablets Effexor XR (venlafaxine extended-release) capsules Pristiq (desvenlafaxine) extended-release tablets Venlafaxine (venlafaxine hydrochloride) extended-release tablets False positive radioisotope investigation test result potentially secondary to a drug interaction with venlafaxine FDA is evaluating the need for regulatory action. Barium sulfate-containing products Entero Vu 24% (barium sulfate) oral suspension E-Z-Disk (barium sulfate) tablets Liquid E-Z-Paque (barium sulfate) oral suspension Readi-Cat 2 (barium sulfate) oral suspension Readi-Cat 2 Smoothie (barium sulfate) oral suspension Taglitol V (barium sulfate) oral suspension Varibar Honey (barium sulfate) oral suspension Varibar Nectar (barium sulfate) oral suspension Varibar Pudding (barium sulfate) oral paste Varibar Thin Honey (barium sulfate) oral suspension Varibar Thin Liquid (barium sulfate) oral suspension Anaphylactic reaction FDA is evaluating the need for regulatory action. Blincyto (blinatumomab) for injection Columvi (glofitamab-gxbm) injection Elrexfio (elranatamab-bcmm) injection Epkinly (epcoritamab-bysp) injection Imdelltra (tarlatamab-dlle) for injection Kimmtrak (tebentafusp-tebn) injection Lunsumio (mosunetuzumab-axgb) injection Talvey (talquetamab-tgvs) injection Tecvayli (teclistamab-cqyv) injection Progressive multifocal leukoencephalopathy FDA is evaluating the need for regulatory action. BRAF kinase inhibitors Braftovi (encorafenib) capsules Ojemda (tovorafenib) for oral suspension; tablets Tafinlar (dabrafenib) capsules; tablets Zelboraf (vemurafenib) tablets Gingival hypertrophy FDA is evaluating the need for regulatory action. Briumvi (ublituximab-xiiy) injection Kesimpta (ofatumumab) injection Acute hepatic failure The "Warnings and Precautions" section of the labeling was updated in August 2025 to include information about liver injury. Example: Briumvi labeling Briumvi (ublituximab-xiiy) injection Kesimpta (ofatumumab) injection Ocrevus (ocrelizumab) injection Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) injection Central nervous system infection FDA is evaluating the need for regulatory action. Crexont (carbidopa and levodopa) extended-release capsules Dhivy (carbidopa and levodopa) tablets Duopa (carbidopa and levodopa) enteral suspension Rytary (carbidopa and levodopa) extended-release capsules Sinemet (carbidopa and levodopa) tablets Sinemet CR (carbidopa and levodopa) sustained-release tablets Stalevo (carbidopa, levodopa and entacapone) tablets Vyalev (foscarbidopa and foslevodopa) injection Seizure FDA is evaluating the need for regulatory action. Crysvita (burosumab-twza) injection Hypercalcemia The "Dosage and Administration", "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in August 2025 to include information about hypercalcemia. Crysvita labeling Dexmedetomidine-containing products Dexmedetomidine injection Precedex (dexmedetomidine hydrochloride) injection Igalmi (dexmedetomidine) sublingual film Diabetes insipidus FDA is evaluating the need for regulatory action. Dupixent (dupilumab) injection Ocular infections, irritations, and inflammation FDA is evaluating the need for regulatory action. Eprontia (topiramate) oral solution Qudexy XR (topiramate) extended-release capsules Qsymia (phentermine and topiramate) extended-release capsules Topamax (topiramate) tablets Topamax Sprinkle (topiramate) capsules Trokendi XR (topiramate) extended-release capsules Hypersensitivity FDA is evaluating the need for regulatory action. Gavreto (pralsetinib) capsules Chylothorax FDA is evaluating the need for regulatory action. Glucagon-like peptide-1 (GLP-1) receptor agonists Adlyxin (lixisenatide) injection Bydureon (exenatide) for extended-release injectable suspension Bydureon BCise (exenatide extended-release) injectable suspension Byetta (exenatide) injection Mounjaro (tirzepatide) injection Ozempic (semaglutide) injection Rybelsus (semaglutide) tablets Saxenda (liraglutide) injection Soliqua 100/33 (insulin glargine and lixisenatide) injection Trulicity (dulaglutide) injection Victoza (liraglutide) injection Wegovy (semaglutide) injection Xultophy 100/3.6 (insulin degludec and liraglutide) injection Zepbound (tirzepatide) injection Intestinal obstruction and fecal impaction FDA is evaluating the need for regulatory action. Imbruvica (ibrutinib) capsules; tablets; oral suspension Nail and nail bed conditions (excluding infections and infestations) FDA is evaluating the need for regulatory action. MEK inhibitors Avmapki Fakzynja Co-pack (avutometinib capsules; defactinib tablets) Cotellic (cobimetinib) tablets Mekinist (trametinib) tablets; oral solution Mektovi (binimetinib) tablets Koselugo (selumetinib) capsules Gingival hypertrophy FDA is evaluating the need for regulatory action. Neffy (epinephrine nasal spray) Product storage error FDA is evaluating the need for regulatory action. Nurtec ODT (rimegepant) orally disintegrating tablets Zavzpret (zavegepant) nasal spray Anaphylactic reaction The "Contraindications" and "Warnings and Precautions" sections of the labeling were updated in August 2025 to include information about hypersensitivity reactions, including anaphylaxis. Example: Nurtec ODT labeling Rozlytrek (entrectinib) capsules; oral pellets Brugada syndrome FDA is evaluating the need for regulatory action. Sodium-glucose cotransporter-2 (SGLT2) inhibitors Fournier's gangrene FDA is evaluating the need for regulatory action. Teriparatide injection (a particular generic product) Device malfunction FDA is evaluating the need for regulatory action. Vizamyl (flutemetamol F18 injection) Anaphylactic reaction The "Warnings and Precautions" section of the labeling was updated in June 2025 to include information about anaphylaxis and other serious hypersensitivity reactions. Vizamyl labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug ApprovalBiosimilar

100 Deals associated with Flutemetamol F-18

External Link

KEGG	Wiki	ATC	Drug Bank
D10231	Flutemetamol F-18	V09AX04	DB09151

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Contrast agents	Japan	Nihon Medi-Physics Co., Ltd.	27 Sep 2017
Alzheimer Disease	United States	GE Healthcare, Inc.	25 Oct 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Dementia	Phase 3	Netherlands	GE Healthcare Technologies, Inc.	18 Oct 2012
Cognitive Dysfunction	Phase 3	Sweden	GE Healthcare AG	21 Jun 2012
Cerebral Amyloid Angiopathy	Phase 3	United States	GE Healthcare Holdings, Inc.	01 Dec 2009
Hydrocephalus, Normal Pressure	Phase 3	United States	GE Healthcare Holdings, Inc.	01 Dec 2009
Mild cognitive disorder	Phase 3	United States	GE Healthcare Holdings, Inc.	01 Dec 2009
Cognition Disorders	Phase 1	China	Tianjin Hengrui Pharmaceutical Co., Ltd	17 Apr 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02317783 (CTgov)	Phase 2	Cognitive Dysfunction \| Breast Cancer	15	Functional Magnetic Resonance Imaging (fMRI)+[18F]fluoro-2-deoxy-D-glucose (FDG)+[18F]Flutemetamol	sclyhqafuo = cltcmezubb uqnviylgru (tpfxavjtpi, xdmfaesfvh - ytscnowvjm) View more	-	20 Nov 2024
NCT01202994 (CTgov)	Phase 2	Alzheimer Disease	27	18F-Flutemetamol	nvmkbkfanh(gicychxjeu) = asmcgbmlil usodastald (xjvfzxkfrf, 1.30) View more	-	11 Jan 2018
NCT02813070 (CTgov)	Phase 2	Alzheimer Disease \| Mild cognitive disorder	70	[18F] Flutemetamol	iblcpfrmuk = hlyluvkrcy saulfhcsqk (ttlqyumlqp, prutdwxilj - lirmpemufh) View more	-	05 Jun 2017
NCT02813070 (Pubmed)	Phase 2	Alzheimer Disease \| Mild cognitive disorder	70	Flutemetamol F 18 injection (Probable Alzheimer's disease (pAD))	ooxclsrema(lgunxcyeiq) = ukuigtecep dykjdzwumo (dexmzktmrj )	-	01 Apr 2017
NCT01165554 \| NCT02090855 (Pubmed \| Acta Neuropathol Commun)	Phase 3	Cognitive Dysfunction β-amyloid	106	flutemetamol F 18	txktwhtqox(lizszuuwhq) = nlkjakdmpc oluksxzsuq (lnovxqxwpf ) View more	-	01 Dec 2016
NCT01165554 (Pubmed \| JAMA Neurol) Manual	Phase 3	Alzheimer Disease	176	Flutemetamol	rfhyozhpvi(smtwvzzuvh) = rnqrmqsquz qnhdnaccof (iyghakyrqd ) View more	Positive	01 Mar 2015
NCT01092546 (CTgov)	Phase 3	Hydrocephalus, Normal Pressure \| Cerebral Amyloid Angiopathy	12	Flutemetamol	iitnmmwzux = meaxoqczwd gvqiqljowt (gzntuawefj, lpisonmprx - qylkyswnix) View more	-	19 Nov 2013
NCT01265394 (CTgov)	Phase 3	Alzheimer Disease	218	[18F] Flutemetamol	yyebnjujjg(typevpzegp) = wzvtlnyjfr qbkazhfxdg (ohmrdesbqa, mwtzladbfc - vfyowaylcn) View more	-	21 Jun 2013
NCT01053312 (CTgov)	Phase 3	Hydrocephalus, Normal Pressure \| Cerebral Amyloid Angiopathy	7	flutemetamol (Subject 201-0001)	qhwwxyyony = vnascvtbca wampxwixvj (csjymururq, hpejkkhsoy - nlxjzjrwoi) View more	-	05 Jun 2012
NCT01053312 (CTgov)	Phase 3		7	flutemetamol (Subject 201-0002)	qhwwxyyony = ycdvfbzspx wampxwixvj (csjymururq, sfyubhmeww - kpwpsnkenm) View more	-	05 Jun 2012

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