by
Gus Iversen, Editor in Chief | February 02, 2026
GE HealthCare has received 510(k) FDA clearance for MIM LesionID Pro, an AI-powered software designed to streamline whole-body tumor burden analysis in PSMA PET/CT and SPECT/CT imaging.
Part of the company’s MIM software portfolio, the new tool automates preprocessing steps that are traditionally time-consuming, including segmentation of disease-specific radiotracer uptake while excluding normal physiological uptake. The software aims to support clinicians in determining eligibility for radiopharmaceutical therapy and monitoring patient response over the course of treatment.
The Chicago-based company developed MIM LesionID Pro in collaboration with theranostics specialists, with the goal of making total tumor burden (TTB) analysis more practical for routine clinical workflows. Historically, whole-body tumor burden quantification has required manual input, limiting its widespread use despite its relevance in monitoring treatment progress.
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With the new tool, users can send patient data through a one-click process that delivers AI-generated segmentation of PSMA uptake across the body. The software also enables longitudinal tracking of disease over multiple therapy cycles, providing reviewable and editable data to confirm quantitative TTB results.
“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 ... this innovative digital tool simplifies a complex process and brings us closer to realizing the full potential of theranostics and personalized medicine.”
The tool integrates MIM Contour ProtégéAI+ for AI-assisted segmentation, and includes reporting features designed to improve clinician workflow. Visual outputs can also be shared with patients and referring providers, supporting more informed clinical discussions.
GE HealthCare continues to position its AI-enabled solutions as part of a broader strategy to enhance precision medicine and clinical decision support across imaging and treatment pathways.
