GE HealthCare Gets FDA 510(k) Clearance for MIM LesionID™ Pro

The platform could transform whole-body tumor burden analysis.

The MIM LesionID Pro
The MIM LesionID Pro
GE Healthcare

GE HealthCare has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for MIM LesionID™ Pro, an innovative solution from its MIM software portfolio that transforms whole-body tumor burden analysis for PSMA PET/CT and SPECT/CT studies into a significantly simplified process.

Designed in collaboration with theranostics practitioners, MIM LesionID Pro features intuitive, user-friendly tools and AI-powered automation aimed at making whole-body tumor burden analysis more feasible to incorporate into routine clinical practice—to ultimately reduce physician effort in obtaining patient-specific insights to aid in confident decision-making.

LesionID Pro is not yet available for sale.

Theranostics is a personalized approach in nuclear medicine that uses diagnostic tools to precisely diagnose and monitor disease, enabling a targeted delivery of therapy to patients. Successful outcomes rely on various factors, including patient-specific insights to help guide and monitor treatment as well as assessing whole-body tumor burden as an important indicator of disease.

Measuring the whole-body tumor burden has historically been a challenge in theranostics, requiring manual, time-intensive analysis. As a result, it hasn’t become a standard practice and still requires support to simplify measurement methods to be more widely adopted.[i]

MIM LesionID Pro aims to address this head-on. With one click, patient data is sent through the software, and clinicians obtain automated segmentation of whole body PSMA uptake with normal uptake removed for review, enabling a qualitative view of a patient’s disease across the body, as well as changes over time, which the user can review and edit to confirm the quantitative total tumor burden (TTB) results.

In addition to eliminating manual pre-processing through AI-powered automation and algorithm enhancements, MIM LesionID Pro helps clinicians quantify and longitudinally track changes in disease over multiple cycles of therapy. Clinicians are supported with AI-powered segmentation delivered by MIM Contour ProtégéAI+ to exclude physiological uptake in automated TTB segmentation, and flexible viewing and reporting tools designed to enhance user experience, making the review process easier and helping accelerate time-to-report.

MIM LesionID Pro also provides visuals that can then be shared with patients and referring physicians to help better understand the trajectory of their prostate cancer.

[i] John, Nikeith, Sarennya Pathmanandavel, Megan Crumbaker, et al. “177Lu-PSMA SPECT Quantitation at 6 Weeks (Dose 2) Predicts Short Progression-Free Survival for Patients Undergoing 177Lu-PSMA-I&T Therapy.” Journal of Nuclear Medicine 64, no. 3 (March 2023): 410–415. https://doi.org/10.2967/jnumed.122.264677.

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