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FDA clears Claritas' PET segmentation and quantification software

by Gus Iversen, Editor in Chief | August 19, 2025
Molecular Imaging
Claritas NucMed Technologies has received FDA clearance for its iPETcertum software, designed to assist with image enhancement, automated segmentation, and quantitative analysis in PET and PET/CT scans.

The UK-based company developed iPETcertum to streamline image review by reducing the time physicians spend on manual segmentation. The tool automatically identifies regions of interest such as tumors or lesions, based on clinician-defined thresholds for standardized uptake values (SUV) and volume. The results are visualized in a single-click interface, intended to speed up image interpretation while supporting diagnostic consistency.

The software’s enhancement capabilities are aimed at improving the clarity of noisy scans, particularly those acquired with reduced isotope doses or shorter acquisition times. According to the company, the process suppresses noise without introducing artifacts or losing detail in areas of low uptake.
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“Not only is manual examination and annotation of oncologic PET-CT labour-intensive, demanding high levels of expertise, it also faces the challenge of the risk of human error, leading to potential omission of especially small lesions and tumours with low isotope uptake,” said Dr. Fernando Salis, chief medical officer of Claritas NucMed Technologies and a practicing nuclear medicine physician in Brazil.

“iPETcertum is a powerful and effective tool that can assist clinicians by removing the labour-intensive task of manual segmentation, freeing up our time to focus on diagnostics and decision making,” Salis said. “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.”

The software is vendor-neutral and supports all common radionuclides. It can be used with full-body or region-specific PET and PET/CT scans, and is designed for integration with existing clinical workflows.

Claritas NucMed Technologies is a subsidiary of Claritas HealthTech Ltd., which focuses on AI-driven medical image processing and diagnostics.

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