aPROMISE X
EXINI Diagnostics ABaPROMISE X is a software platform for healthcare professionals and researchers that assists in accepting, transferring, storing, manipulating, quantifying, and reporting digital medical images from PSMA PET/CT scans. It allows users to visualize multiple scans, mark regions of interest, and perform quantitative analysis to help identify suspicious lesions in oncology cases, improving clinical efficiency and consistency.
Intended Use
aPROMISE X is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images from nuclear medicine imaging using PSMA PET/CT. It provides PACS tools and oncology clinical applications including marking of regions of interest and quantitative analysis.
Technology
aPROMISE X is a web-based software platform accessed via cloud or local server that supports DICOM 3 standard whole-body PSMA PET and CT imaging data. It enables upload via DICOM transmission or manual input, supports multiple scans per patient, and provides multi-panel visualization (PET, CT, fusion, MIP). The system uses AI-enabled automated segmentation of skeleton and soft tissue organs and a machine-learning model to detect and segment hotspots. Quantitative analysis including SUV metrics and lesion volumes are computed for each region of interest. User interaction includes quality control verification and electronic signing of reports.
Performance
Performance testing included digital phantom validation demonstrating accuracy and linearity of quantification metrics, comparison with the predicate device showing equivalent performance, and a clinical analytical study proving improved reproducibility, efficiency, and consistent quantitative assessment by aPROMISE X compared to manual clinician measurements. Software verification and validation were conducted in line with FDA guidance for moderate risk software. No animal or clinical studies were required.
Predicate Devices
No predicate devices specified
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