GE HealthCare (GEHC) has submitted its MIM KineticID kinetic modeling software for 510(k) clearance with the U.S. Food and Drug Administration (FDA).
The software is designed for dynamic PET imaging workflows and quantitative kinetic modeling by tracking how radiotracers behave over time in both tissue and blood, moving beyond static, single-timepoint imaging, according to the company. Key capabilities include the following:
- 4D visualization, Patlak analysis, and customizable curve fitting for kinetic modeling and parametric imaging.
- Automated labeling and flexible modeling tools for tracer concentration in plasma and tissue.
- Side-by-side comparison of multiple tracers, such as F-18 FDG and prostate-specific membrane antigen (PSMA).
- Support for DICOM data from any PET system, with multimodality fusion and therapy response assessment.
MIM KineticID is not yet available for sale in the U.S., Europe, or Canada pending regulatory clearance, the company noted.
