FDA Clears AI Software for PSMA PET/CT and SPECT/CT Tumor Burden Analysis

The Food and Drug Administration (FDA) has granted 510(k) clearance for the MIM LesionID™ Pro software, which may put an end to manual, time-intensive assessment of whole-body tumor burden with PSMA PET/CT and SPECT/CT.

With one click, the MIM LesionID Pro software provides artificial intelligence (AI) automated segmentation of whole body uptake of prostate-specific membrane antigen (PSMA) and subsequent removal of normal uptake in order to facilitate assessment by nuclear medicine physicians, according to GE HealthCare, the manufacturer of the MIM LesionID Pro software.

The company said the MIM LesionID Pro software, introduced at the 2025 SNMMI conference, facilitates efficient assessments of the extent of tumor burden as well as monitoring of changes in quantitative total tumor burden over time.

"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, the president and CEO of molecular imaging and computed tomography for GE HealthCare.