FDA Radiology AI Devices

The syngo.via RT Image Suite by Siemens is a software tool that helps clinicians visualize, manipulate, and contour medical images in 3D and 4D across multiple imaging modalities. It supports the preparation of radiation therapy treatments by allowing the viewing and editing of contours for tumors and organs-at-risk, managing points of interest, and generating synthetic CT images using AI algorithms. This tool improves the accuracy and efficiency of treatment planning for patients undergoing radiation therapy.

ClariCT.AI is an AI-powered software solution that enhances the quality of CT images by reducing noise, especially in low-dose scans. This helps radiologists get clearer images to improve diagnosis while potentially lowering patient radiation exposure. It is compatible with CT images from any manufacturer and integrates seamlessly with medical IT systems.

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.

Us2.v1 is an AI-powered software platform that automatically processes and analyzes transthoracic cardiac ultrasound images to measure key cardiac structural and functional parameters. It helps cardiologists and healthcare providers by producing comprehensive reports to support clinical decision-making for adult patients.

Volpara Imaging Software is an AI-driven tool that processes raw digital mammography and tomosynthesis images to generate detailed breast density maps and quantitative metrics. It helps healthcare professionals assess breast composition by providing volumetric measurements and BI-RADS density categories as adjunctive information in breast cancer screening and assessment.

GI Genius is an artificial intelligence-based software device designed to assist endoscopists during colonoscopy. It analyzes live video images from standard white-light endoscopy in real time and highlights abnormal colonic mucosal lesions such as polyps and adenomas to aid detection. By providing visual markers on the video display, it helps clinicians identify lesions that might be missed, improving detection rates and supporting clinical decision making.

Change Healthcare Anatomical AI is a standalone software that uses AI algorithms to analyze CT and MR images, automatically identifying anatomical regions and creating detailed anatomic descriptors. This information helps clinicians and integrated healthcare systems quickly locate and categorize relevant images or studies without altering the original images.

Oxehealth Vital Signs is a software device that uses optical cameras to noninvasively measure pulse rate and estimated breathing rate from video footage of patients. It facilitates vital sign monitoring in single-occupancy hospital rooms and care environments without physical contact, helping clinicians monitor patients effectively, especially those who do not require critical or continuous monitoring.

Chest-CAD is a computer-assisted detection software that uses machine learning to analyze adult chest X-rays. It identifies and highlights suspicious regions in various categories like cardiac, lungs, bones, and more, assisting physicians with concurrent reading during diagnosis. This helps improve detection accuracy and clinical workflow efficiency.

PowerLook Density Assessment V4.0 is a software tool that analyzes synthetic 2D images from digital breast tomosynthesis exams to provide breast density categories using the ACR BI-RADS 5th Edition. This helps radiologists assess breast tissue composition as an adjunctive aid, improving breast cancer screening processes.