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GE HealthCare Gets FDA Clearance for AI Software to Simplify Tumor Burden Analysis

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GE HealthCare has received 510(k) clearance from the U.S. Food and Drug Administration for MIM LesionID™ Pro, an AI-powered software designed to simplify whole-body tumor burden analysis for PSMA PET/CT and SPECT/CT studies.

Part of GE HealthCare’s MIM software portfolio, MIM LesionID Pro uses automated pre-processing and AI-driven segmentation to reduce the manual effort required from physicians. With a single click, the software processes patient data, removes normal uptake and presents an automated whole-body view of tumor involvement. Clinicians can review and edit results to confirm quantitative total tumor burden and track changes over time.

The software is designed to support theranostics workflows, helping physicians assess whether patients are suitable for radiopharmaceutical therapy and monitor treatment response. By reducing time-consuming manual analysis, MIM LesionID Pro aims to make whole-body tumor burden assessment easier to integrate into routine clinical practice and support faster more confident clinical decisions.

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Written by
Raunak Yadav

Tech and AI enthusiast with a strong eye for clear and engaging content!

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