There are an estimated 4.5 million PET scans performed globally each year, with PET imaging continuing to expand as new tracers and theranostic workflows emerge. Industry reports indicate that 67 percent of PET imaging sites expect procedure volumes to increase over the next 12 months. As volumes grow, health systems are challenged to improve throughput, expand patient access, and maximize existing scanner capacity. The new clearance expands Subtle Medical’s PET market reach to include imaging providers utilizing advanced radiotracers, theranostics programs, and health systems operating their own cyclotrons.

Building on the company’s previous SubtlePET product, SubtleHD(PET) is built on a new AI model architecture providing improved image enhancement performance, greater SUVmax quantitation accuracy, and expanded compatibility across all FDA-approved radiotracers, including emerging molecular imaging agents beyond traditional FDG imaging. The software was validated across a range of accelerated low-count PET acquisitions and includes the ability to adjust the denoising level to the radiologist’s preference. It also leverages anatomical CT data to further improve PET image reconstruction quality and quantitative consistency.