GE HealthCare has submitted MIM KineticID for FDA 510(k) review, moving the dynamic PET modeling software into pending regulatory status.
The software is designed to support dynamic PET workflows and quantitative kinetic modeling. GE HealthCare said the approach tracks how radiotracers behave over time in tissue and blood, rather than relying only on static PET images.
Clinical PET interpretation often uses static images, anatomical imaging, prior exams, histopathology, and simplified measurements such as standardized uptake value. The company said dynamic PET may add information about tracer availability, tissue uptake, and blood-pool behavior.
Planned capabilities include 4D visualization, Patlak analysis, customizable curve fitting, kinetic modeling, and parametric imaging. GE HealthCare said the software is also designed to support rapid whole-body dynamic analysis.
Workflow features include automated labeling and flexible modeling tools for tracer concentration in plasma and tissue. The software is also designed to compare multiple tracers side by side, including FDG and PSMA, according to the company.
MIM KineticID is part of GE HealthCare’s vendor-neutral, multimodality MIM ecosystem. The company said the software supports DICOM data from any PET system and includes multimodality fusion, therapy-response assessment, and integrated analysis.
Regulatory clearance remains pending. GE HealthCare said MIM KineticID is not CE marked and is not available for sale in the U.S., Europe, Canada, or any other region.
Companies:GE HealthCare, U.S. Food and Drug Administration
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