FDA Radiology AI Devices

TRAQinform IQ is a cloud-based software tool designed to aid medical professionals by providing quantitative analysis of lesions identified in PET/CT scans. It uses AI techniques such as machine learning for anatomical and skeletal segmentation and automates matching and quantitative assessment of regions of interest between multiple scans. The device generates detailed reports on lesion volume and tracer uptake changes over time, supporting clinicians in oncology and nuclear medicine to monitor disease progression and treatment response.

SwiftMR is a software tool that automatically enhances MRI images by reducing noise and increasing sharpness using deep learning techniques. It integrates with medical imaging systems (PACS or MRI machines) to improve image quality, aiding radiologists and clinicians in better interpreting MRI scans.

aPROMISE 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.

aPROMISE is a cloud-based software platform that helps healthcare professionals and researchers manage, review, and analyze PSMA PET/CT medical images. It offers tools to mark and quantify regions of interest, supporting oncology care by providing quantitative analysis and report generation to inform patient management decisions.

Quantitative Total Extensible Imaging (QTxI) is a software tool that helps medical professionals manage and evaluate digital medical images from CT and PET scans. It supports tasks such as storing, retrieving, and displaying images, as well as identifying and analyzing regions of interest (ROIs) in full or partial body scans with 3D visualization. This software aids clinicians by automating quantification and monitoring changes in imaging data to improve diagnostic and treatment decision workflows.