GE HealthCare Secures FDA Clearance for MIM LesionID Pro Tumor Burden Analysis Software
GE HealthCare has received FDA 510(k) clearance for MIM LesionID Pro, a software solution designed to simplify whole-body tumor burden analysis in PSMA PET/CT and SPECT/CT imaging. Part of the company’s MIM software portfolio, the tool uses automated preprocessing and AI-driven segmentation to reduce the manual workload traditionally required for assessing disease extent in nuclear medicine studies.
Whole-body tumor burden plays an important role in theranostics, a personalized approach that combines diagnostic imaging with targeted radiopharmaceutical therapy. Despite its clinical relevance, tumor burden measurement has historically required time-intensive manual analysis, limiting routine adoption. MIM LesionID Pro aims to address this challenge by automating segmentation of PSMA uptake while excluding normal physiological activity, allowing clinicians to review and confirm quantitative results with minimal manual adjustment.
With a single workflow step, patient imaging data is processed to generate a qualitative overview of disease distribution across the body, as well as quantitative metrics that can be tracked over time. The software supports longitudinal assessment across multiple therapy cycles, helping clinicians monitor treatment response and evaluate patient suitability for radiopharmaceutical therapies.
“The FDA clearance of MIM LesionID Pro is a powerful step forward in our commitment to deliver intelligent, connected solutions that help clinicians make fast, confident decisions,” said Jean-Luc Procaccini, President and CEO of Molecular Imaging and Computed Tomography at GE HealthCare. “By automating whole-body tumor burden analysis in PSMA PET/CT and SPECT/CT studies, this innovative digital tool simplifies a complex process and brings us closer to realizing the full potential of theranostics and personalized medicine.”
In addition to automated segmentation, MIM LesionID Pro integrates visualization and reporting tools designed to streamline review and reduce time to report. The software also enables results to be shared more clearly with referring physicians and patients, supporting communication around disease progression and treatment planning as theranostic approaches continue to expand in clinical practice.
