GE HealthCare advances 4D dynamic PET imaging with U.S. FDA 510(k) submission of MIM KineticID™, designed to bring quantitative insight to disease assessment

• GE HealthCare reaches 510(k) pending milestone for MIM KineticID,ⁱ expanding access to dynamic PET imaging and quantitative kinetic modeling
• This solution is designed to bring a fourth dimension to imaging by enabling clinicians and researchers to model and assess the spatio-temporal biodistribution of tracers – how they behave over time – and support deep and precise disease insights

CHICAGO — May 29, 2026 — GE HealthCare today announced that its MIM KineticID™ⁱ modeling software is now 510(k) pending with the U.S. Food and Drug Administration, marking a key milestone in expanding access to advanced quantitative imaging. Designed to transform how clinicians and researchers assess disease, this innovative solution is engineered to enable dynamic PET workflows and kinetic modeling to deliver a clear, data-driven view of how radiotracers behave across the body over time – helping support more confident clinical and research decisions.

In clinical practice, PET imaging is typically based on visual interpretation of static images, often supported by anatomical imaging, prior scans, patient histopathology data and simplified metrics like standardized uptake value (SUV). Because these methods reflect only a single point in time, they don’t fully capture how a tracer behaves in the body – including how it behaves in the blood and its availability within the tissue of interest – making it more difficult for clinicians to accurately quantify tracer uptake and distinguish between malignant and inflammatory lesions.

To address this limitation, dynamic PET imaging captures how tracers behave over time in both tissue and blood, enabling a more accurate and fully quantitative assessment of disease. Kinetic modeling then translates this information into meaningful insights by describing the tracer’s journey from injection to uptake and eventual clearance.

“Dynamic PET and kinetic modeling are transforming how we understand disease,” shares Prof Martin Huellner, MD, Senior Physician, Vice Director of Department, Department of Nuclear Medicine, Zurich University Hospital. “Instead of relying on a single moment in time, we can track how a tracer moves through the body and uncover what’s driving what we see – providing a far more accurate and meaningful picture of underlying biology. This capability is increasingly valuable in clinical care and research, supporting applications in oncology, cardiology, neurology, and the development of new tracers and therapies.”

To empower clinicians and researchers, MIM KineticID is designed to make advanced dynamic imaging more practical and accessible. It is engineered to deliver a comprehensive workflow for kinetic modeling and parametric imaging, with intuitive 4D visualization, Patlak analysis (both absolute and relative), and customizable curve fitting.

By tracking how radiotracers move through the body, MIM KineticID is designed to enable clinicians and researchers to move beyond visual interpretation to more precise, reproducible measurements of key biological processes, such as tracer uptake rate and metabolic activity.

“As healthcare advances toward more personalized care, the expectations for imaging are changing,” shares J Anders, General Manager, MIM, GE HealthCare. “Clinicians and researchers need tools that go beyond static images to deliver deeper, quantitative insight into disease biology. With MIM KineticID, we’re not only addressing today’s need for more accessible dynamic imaging, but also creating a platform that can adapt and scale as new tracers, therapies, and clinical questions emerge.”

The solution is also designed to support rapid whole-body dynamic analysis with automated labeling, advanced and flexible modeling tools for both the tracer concentration in plasma (input function) and tissue, and the ability to compare multiple tracers – such as FDG and PSMA – side by side. These features aim to enable users to easily visualize, summarize, and export results to support collaboration and more informed decision-making.

As part of the vendor-neutral, multi-modality MIM ecosystem, MIM KineticID supports DICOM data from any PET system. The platform also enables multi-modality fusion, therapy response assessment, and integrated analysis – helping streamline workflows and maximize the value of imaging data.

To learn more about GE HealthCare’s portfolio of MIM software solutions, please visit gehealthcare.com. 
[i] 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.