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GEHC gains FDA clearance for MIM LesionID Pro

GE HealthCare (GEHC) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for MIM LesionID Pro.

The software analyzes whole-body tumor burden for prostate-specific membrane antigen (PSMA) PET/CT and SPECT/CT studies. 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. GEHC said this makes way for a qualitative view of a patient’s disease across the body, as well as changes over time. Users can review and edit to confirm the quantitative total tumor burden results.

The software’s AI-powered automation can help physicians assess the suitability of radiopharmaceutical therapy as a treatment option for patients, as well as monitor their responses during treatment.

Clinicians are supported with AI-powered segmentation delivered by MIM Contour ProtégéAI+ to exclude physiological uptake in automated total tumor burden segmentation. MIM LesionID Pro also provides visuals that can be shared with patients and referring physicians to help better understand the trajectory of their prostate cancer.

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