FDA Radiology AI Devices

The EyeBOX is an eye-tracking device designed to assist clinicians in diagnosing concussion by analyzing eye movements. Patients watch a video on a screen while a near-infrared camera records their eye gaze data. The device processes this data using advanced algorithms to detect subtle abnormalities in eye movement that indicate concussion, helping doctors make timely and accurate assessments.

SIGNA Artist is a magnetic resonance imaging (MRI) scanner designed to produce high-resolution diagnostic images of the whole body. It supports multiple imaging planes and can generate a variety of images including axial, sagittal, coronal, spectroscopic, parametric maps, and dynamic images. The AIR Recon DL software feature enhances image quality by improving signal-to-noise ratio and sharpness, assisting clinicians in diagnosis through clearer MRI images.

AVIEW by Coreline Soft is a comprehensive medical imaging software that processes CT images of the lungs and heart. It helps physicians analyze lung tissue quantitatively, characterize lung nodules, evaluate coronary artery calcium, and monitor progression of lung disease. The software provides advanced segmentation, registration, quantitative metrics, and reporting tools, integrating AI techniques such as deep learning and CAD to enhance diagnostic support and workflow efficiency.

BriefCase by Aidoc Medical, Ltd. is an AI-powered software that analyzes contrast-enhanced chest CT scans to detect incidental pulmonary embolism. The software notifies radiologists of suspected positive cases via a desktop application, helping prioritize urgent cases for faster review without replacing the standard diagnostic process. It supports workflow improvements by flagging cases early, potentially saving hours in time to examination.

TOMTEC-ARENA is a clinical software package designed for reviewing, quantifying, and reporting medical imaging data primarily related to cardiovascular, fetal, and abdominal structures. It helps clinicians assess structures and functions from various imaging modalities in multiple dimensions, facilitating disease diagnosis through detailed quantifications and advanced visualization tools.

Limbus Contour is a software tool that uses machine learning to automatically create contours of normal anatomical structures on CT and MRI images for use in radiation therapy planning. It helps trained clinicians by providing optimized contours that can be imported into treatment planning systems, improving efficiency and accuracy in defining healthy tissues.

Syngo.via RT Image Suite is a medical imaging software tool that helps clinicians visualize and manipulate 3D and 4D images from multiple modalities like CT, PET, and MRI in preparation for radiation therapy treatments. It provides advanced contouring tools including AI-based automatic organ segmentation, multi-modality image fusion, and supports creating treatment plans to improve accuracy and efficiency in radiation therapy workflows.

AccipioIx is an AI-based software that processes non-contrast head CT scans to identify signs of acute intracranial hemorrhage. It helps clinicians prioritize urgent cases for faster review by analyzing images and flagging suspected hemorrhages, improving workflow efficiency in acute care settings.

VIDA|vision is an interactive imaging software that helps physicians analyze CT scans of the lungs. It uses deep learning algorithms to automatically segment lung regions and provides detailed quantitative analyses to assist in diagnosing and monitoring lung diseases such as lung cancer, COPD, and asthma. This software reconstructs two-dimensional CT images into 3D views and generates detailed reports, streamlining the workflow and reducing manual effort for clinicians.

HYPER DLR is a software-only device that applies a pre-trained convolutional neural network to reduce noise in fluorodeoxyglucose (FDG) PET images. It improves image quality by distinguishing and removing noise components while preserving image details, aiding radiologists and nuclear medicine physicians in better image interpretation.