FDA Radiology AI Devices

Aquilion Serve (TSX-307A/1) V1.3 is a whole-body multi-slice helical CT scanner that captures detailed cross-sectional volume images including the head. It incorporates AiCE, an AI-powered noise reduction algorithm using deep convolutional neural networks to improve image quality and reduce noise. This helps clinicians obtain clearer images for specialized studies across multiple anatomical regions, aiding diagnosis and treatment planning while potentially reducing radiation dose.

NEUROShield is a software tool that automatically labels, visualizes, and measures the volume of the hippocampus brain structure using 3D MRI images. It uses AI deep learning models to assist neurologists and neuroradiologists by providing fast, accurate volumetric analysis, helping in clinical decision-making and research.

Lung-CAD is an AI-powered software that helps physicians by analyzing chest X-rays to identify areas showing interstitial thickening. It highlights these areas with bounding boxes, serving as a concurrent reading aid to improve detection. It does not replace physicians but supports them in interpreting lung images more effectively in adults.

The XIDF-AWS801 Angio Workstation (Alphenix Workstation), V9.5, by Canon Medical Systems is a medical imaging system used alongside interventional angiography equipment. It provides 2D and 3D imaging to assist clinicians in visualizing blood vessels throughout the body during catheter procedures. The device incorporates AI deep learning software to improve the detection and stabilization of stent markers, enhancing image clarity and aiding in diagnosis and treatment planning.

The Cartesion Prime (PCD-1000A/3) V10.15 is a PET/CT emission computed tomography system designed for diagnostic imaging. It helps clinicians by producing high-quality fused metabolic and anatomical images through PET and CT scans, improved by AI-driven noise reduction and motion correction. This aids in the evaluation, diagnosis, and treatment planning of various diseases such as cancer, cardiovascular and neurological disorders.

Alignment System Cranial by Brainlab AG is a surgical navigation system designed to assist surgeons during cranial stereotactic procedures such as biopsies of intracranial lesions and placement of stereo-electroencephalography electrodes. It integrates optical tracking with advanced software and hardware to precisely guide surgical instruments, improving accuracy and safety. The system includes artificial intelligence features that aid in patient registration processes by detecting anatomical landmarks, enhancing surgical planning and execution.

Cleerly ISCHEMIA is an AI-based software tool that analyzes coronary CT angiography images to help clinicians detect likely ischemia in coronary vessels. It works as an add-on to Cleerly Labs software, providing a non-invasive decision support tool to assess the functional significance of coronary artery disease, aiding patient management alongside traditional diagnostic methods.

The CorVista System is a non-invasive medical device combining hardware and software to analyze physiological signals from patients with cardiovascular symptoms. Using machine learning, it provides healthcare providers with a likelihood of significant coronary artery disease to aid diagnosis, integrating clinical judgment and patient history. This helps clinicians identify patients who may need further evaluation or treatment.

DeepXray is an AI-powered software that helps medical professionals analyze knee X-rays by automatically measuring joint space width and assessing signs of osteoarthritis such as sclerosis, joint space narrowing, and osteophytes. It supports clinicians by providing detailed grading based on established radiographic criteria and offers an interactive report for review and editing before finalizing.

The CARTO™ 3 EP Navigation System Software V8.0 is a catheter-based cardiac mapping system that helps clinicians map the electrical activity and anatomy of the heart in 3D during electrophysiological procedures. Using specialized catheters and advanced mapping technologies including machine learning algorithms, it improves visualization and identification of complex heart signals to guide interventions and improve procedural outcomes.