GE HealthCare receives FDA 510(k) clearance for MIM LesionID™ Pro, helping transform whole-body tumor burden analysis

• Recently FDA-cleared is GE HealthCare’s MIM LesionID Pro[i] with automated pre-processing, which aims to reduce physician effort in total tumor burden analysis for PSMA PET/CT and SPECT/CT studies, to help empower fast, confident decisions.
• The software’s AI-powered automation can aid physicians in assessing suitability of radiopharmaceutical therapy as a treatment option for their patients as well as monitoring response for patients undergoing treatment.

CHICAGO – GE HealthCare (Nasdaq: GEHC) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for MIM LesionID™ Pro[i], 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 leading 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.

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.[ii] 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.

"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. 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,” said Jean-Luc Procaccini, President & CEO, Molecular Imaging & Computed Tomography, GE HealthCare. “It’s a clear example of how we’re advancing precision care—connecting insights across platforms to support smarter care delivery and enable better patient outcomes."

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.

MIM LesionID Pro reinforces GE HealthCare’s commitment to advancing personalized medicine through integrated, AI-enabled solutions that aim to help improve both clinical efficiency and patient outcomes. Streamlining tumor burden analysis through AI-powered automation, supports the company’s broader precision care strategy to advance personalized medicine and empower clinicians with actionable insights across the care continuum. To find out more about the new MIM LesionID Pro, visit gehealthcare.com.

[i] LesionID Pro is not available for sale.

[ii] 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.