News|Articles|August 12, 2025

FDA Clears Automated Segmentation and Quantification Tool for PET Scans

Author(s)Jeff Hall

The iPETcertum software reportedly provides automated segmentation and enhanced visualization of regions of interest on PET scans with a single click.

The Food and Drug Administration (FDA) has granted 510(k) clearance for the iPETcertum™ software, which offers automated segmentation and improved visualization for positron emission tomography (PET).

While manual segmentation to obtain whole body standardized uptake values (SUVs) and volumes with PET would take hours, iPETcertum provides automated segmentation with one click, according to Claritas NucMed Technologies, the developer of the iPETcertum software.

In addition to the automated segmentation and quantification capabilities, Claritas NucMed Technologies emphasized the noise suppression benefits with iPETcertum that allow clinicians to obtain quality PET imaging with reduced isotope dosing and/or reduced scan time.

“IPETcertum™ is a powerful and effective tool that can assist clinicians by removing the (labor)-intensive task of manual segmentation, freeing up our time to focus on diagnostics and decision making. Further, as iPETcertum removes the issue of subjectivity, as it provides values based on uptake values at a voxel level, it can be used as an effective tool for measuring and monitoring of treatment progress over time,” noted Fernando Salis, M.D. Ph.D., the chief medical officer of Claritas NucMed Technologies.


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