iPETcertum Receives FDA Clearance for Assisting in PET, PET-CT/MRI Scans for Patients With Cancer and Suspicious Lesions

The software device iPETcertum, which is used for the enhancement, automated segmentation, and quantification of PET scans, had been granted clearance by the FDA.1

iPETcertum allows for the single-click visualization of tumors or lesions of interest via its segmentation feature in PET and PET-CT/MRI scans. This enables fast access to accurate whole body standard uptake values and volumes for review and analysis that would take several hours with manual segmentation. Additionally, investigator-defined parameters, including minimum and maximum thresholds of standard uptake and volume values, are used to create the segmentation regions.

Moreover, iPETcertum features advanced image enhancement that removes noise, which improves visibility in PET and PET-CT/MRI scans. This process introduces no new features or artifacts, only suppressing noise and ensuring that fine lesions or low uptake areas are not missed. Therefore, the software can yield reliable diagnostic quality images and scans using noisy scans obtained with reduced isotope doses and/or reduced scan times.

The rate of PET imaging is steadily increasing due to factors including the increasing prevalence of chronic disease, advancement in treatment technologies, aging populations, and the wider use of PET scanning beyond patients with cancer. These could include cardiac, vascular, and neurologic conditions. Current practices for the review and analysis of PET imaging for the purposes of treatment decision-making and patient monitoring necessitate significant time, which could often last several hours.

“Not only is manual examination and annotation of oncologic PET-CT labor-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 tumors with low isotope uptake,” Fernando Salis, MD, PhD, chief marketing officer of Claritas NucMed Technologies, Brazil, stated in a news release.

Beyond its noise reduction capabilities, iPETcertum can sharpen organ boundaries and achieve “super resolution.”2 The algorithm employed by the software can compute the fusion of functional and anatomic data based on non-local means filtering, and creates a uniformly spaced sequence containing slices of a PET scan. It can also input another 3D voxel array with density values from a CT scan or MRI, which needs to at least partially overlap to take advantage of the additional anatomic information. The user can control the sharpness, style, and detail of the visualization.

According to Claritas, iPETcertum can improve the signal-to-noise ratio by 4 to 5 times compared with the original PET scan for images captured with a low contrast dose and/or short duration scans. The technology also reduces root mean square error by 50% for these images.

In terms of scans captured per current standards, iPETcertum improves signal-to-noise ratio by up to 20% and reduces root mean square error by 10% compared with standard scans. Additionally, scan times can be decreased by up to 80% with similar results as a full duration scan.

iPETcertum is agnostic to equipment brand or manufacturer and is compatible with all types of radionuclides.1 The software is able to be easily integrated into existing systems and is effective for PET and PET-CT scans, as well as scans of selected anatomies.

“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,” Salis added in the news release. “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 the measuring and monitoring of treatment progress over time.”

References

1. iPETcertum by Claritas, developed with cutting-edge technology for enhancement, automated segmentation and accurate quantification in PET, PET-CT/MRI scans, receives FDA clearance. News release. Claritas. August 12, 2025. Accessed August 12, 2025. https://www.globenewswire.com/news-release/2025/08/12/3131393/0/en/iPETcertum-by-Claritas-Developed-with-Cutting-Edge-Technology-for-Enhancement-Automated-Segmentation-and-Accurate-Quantification-in-PET-PET-CT-MRI-Scans-Receives-FDA-Clearance.html
2. iPET technology. Claritas. Accessed August 12, 2025. https://claritashealthtech.com/technology-ipet/