FDA Radiology AI Devices

OptimMRI (v2) is a software application that processes MRI brain images to generate detailed 3D annotated models highlighting specific brain regions. It helps clinicians in planning neurosurgical procedures by localizing critical brain nuclei, thus supporting accurate functional planning and improving surgical outcomes.

The i2Contour by MRIMath LLC is a web-based AI-assisted software designed to semi-automatically segment and quantify glioblastoma tumors from MRI scans. It helps trained medical professionals by providing initial tumor contours which can be reviewed and manually adjusted, enabling accurate tumor volume assessments for patients with pathologically confirmed glioblastoma. This facilitates monitoring tumor progression or treatment response but is not intended for primary diagnosis.

AI Platform 2.0 (AIP002) by Exo Imaging is an AI-powered software tool designed to assist healthcare professionals by analyzing ultrasound images of the heart and lungs. It helps detect lung structures and artifacts, and quantifies cardiac functions such as left ventricular ejection fraction and myocardium wall thickness. The tool also provides real-time quality feedback to improve ultrasound image acquisition, aiding clinicians in making better diagnostic assessments for adult patients.

CardIQ Suite is a non-invasive software tool that analyses 2D and 3D CT cardiac images to assist clinicians in visualizing and measuring heart structures and vessels. It provides calcium scoring to evaluate calcified plaques and uses deep learning algorithms to automate segmentation and labeling of heart and coronary arteries, improving diagnostic workflow for cardiovascular diseases.

AISAP Cardio V1.0 is an AI-powered software that analyzes cardiac point-of-care ultrasound images to detect and assess valvular pathologies like regurgitations and stenosis, and measures key cardiac functions such as ejection fraction and chamber sizes. It supports physicians by generating diagnostic reports that aid in interpreting ultrasound images, improving accuracy and efficiency in evaluating heart conditions in adult patients.

MammoScreen 3 is an artificial intelligence software tool designed to assist physicians in interpreting screening mammograms from digital mammography and digital breast tomosynthesis systems. It provides graphical marks indicating suspicious soft-tissue lesions or calcifications, along with a suspicion score and lesion characterization, helping radiologists in their diagnosis and reporting. The software is intended as an aid to, but not a replacement for, the physician's clinical judgment.

The ACUSON Sequoia Diagnostic Ultrasound System family by Siemens Medical Solutions includes multi-purpose, software-controlled ultrasound systems designed to provide detailed images and measurements from inside the body. These systems support various clinical applications including fetal, abdominal, cardiac, musculoskeletal, and vascular imaging, among others. They assist clinicians by offering advanced imaging modes such as 2D, Doppler, elastography, and 3D/4D volume imaging, as well as specialized tools like Ultrasonically-Derived Fat Fraction (UDFF) for managing hepatic steatosis. The systems deliver real-time imaging and measurements to help diagnose and manage a wide range of conditions effectively.

Rayvolve by AZmed SAS is an AI-powered software designed to assist radiologists and emergency physicians in detecting fractures from X-ray images of various musculoskeletal regions in adults and children aged 2 years and older. It enhances fracture diagnosis by automatically highlighting potential fractures on standard radiographic views, improving diagnostic accuracy and workflow efficiency.

MICSI-RMT is a software medical device designed to improve head MRI images by reducing noise, enhancing image quality to assist radiologists. It processes functional and diffusion MRI images without a user interface, outputting enhanced images for better visualization of brain structures and activation maps, aiding in clinical MRI interpretation.

The Swoop Portable MR Imaging System by Hyperfine, Inc. is a portable ultra-low field MRI device designed to image the internal structure of the head. It provides physicians with useful diagnostic images in environments where full diagnostic examination is not practical. The system uses deep learning reconstruction algorithms to improve image quality and is intended for use at the point of care, such as emergency rooms and intensive care units, enhancing access to MRI imaging in diverse clinical settings.