FDA Radiology AI Devices

The EFAI ChestSuite XR Pneumothorax Assessment System is an AI-powered software tool that helps clinicians prioritize chest X-ray cases suspected of pneumothorax. It uses deep learning to analyze posteroanterior chest X-rays and provides case-level notifications in the existing PACS/workstation workflow, facilitating faster identification and assessment of patients who may have pneumothorax. It supports clinical decision-making by aiding in triage but is not intended for stand-alone diagnosis.

The uMR Omega with uWS-MR-MRS is a magnetic resonance imaging (MRI) system combined with advanced software solutions designed for viewing, manipulating, and analyzing MR images. It includes features such as AI-assisted image reconstruction and multiple post-processing tools that aid clinicians in evaluating anatomical and functional information. This helps radiologists and physicians diagnose more effectively by providing enhanced image quality and quantitative assessment capabilities.

EndoNaut is a software system designed to aid physicians during fluoroscopy X-ray guided procedures by overlaying preoperative 3D vascular anatomy onto live fluoroscopy images. It assists in accurately positioning surgical tools and endovascular devices in the chest, abdomen, pelvis, neck, and lower limbs for treatments like aneurysm repair and arterial embolization. This image fusion and navigation tool enhances procedural accuracy, although it does not replace the surgeon's judgment and requires real-time imaging confirmation before device deployment.

Viz LVO is an AI-based software tool designed for hospital networks and clinicians to detect and notify specialists about suspected large vessel occlusions in brain CT angiograms. It facilitates rapid communication and prioritization of cases to improve stroke patient management, providing image previews via a mobile app for informational use to assist timely specialist review.

AI-Rad Companion (Musculoskeletal) is an AI-powered software that analyzes previously acquired CT images to assist radiologists and physicians in evaluating musculoskeletal diseases. It segments, labels vertebrae, measures vertebral heights, and computes mean Hounsfield values to provide detailed quantitative and qualitative analysis, improving assessment and workflow efficiency for clinicians.

Spine CAMP™ is a fully-automated software that analyzes X-ray images of the spine to measure and assess spinal parameters, such as alignment, stability, and motion. It helps healthcare professionals by providing quantitative metrics and visualizations, improving clinical decision-making regarding spinal health and treatments.

AI-Rad Companion Organs RT is a software product by Siemens that uses deep learning to automatically contour organs at risk on CT imaging data. The output contours help radiation oncologists plan external beam radiation therapy by providing accurate anatomical structures for treatment planning. The software processes CT scans, generates contour data in DICOM RTSTRUCT format, and integrates with treatment planning systems to improve clinician workflow and efficiency in radiation therapy preparation.

BriefCase by Aidoc Medical is an AI-powered software that analyzes head CT angiography images to detect suspected large and medium vessel occlusions. It assists trained medical specialists by providing notifications of suspected positive findings to help prioritize and triage cases for faster review. It operates alongside standard workflows without altering original medical images, helping clinicians identify urgent cases more quickly.

Genius AI Detection 2.0 is a software device that uses deep learning AI models to analyze digital breast tomosynthesis (DBT) images. It identifies and marks suspicious soft tissue densities and calcifications, providing confidence scores to aid radiologists during breast cancer screening. The AI improves detection specificity and reduces false positives, supporting clinicians in interpreting 3D mammography exams efficiently and accurately.

QIR Suite is a software tool designed to help medical professionals analyze cardiovascular magnetic resonance images. It uses standard and deep learning algorithms to automate measurements like heart chamber function and blood flow, aiding diagnosis and treatment planning for adult patients with heart conditions.