FDA Radiology AI Devices

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.

The MAGNETOM Viato.Mobile by Siemens is a 1.5 Tesla mobile MRI system designed to be relocated to different locations where imaging services are needed. It produces high-quality MR images of the head, body, and extremities in multiple planes and can also be used during interventional procedures. This helps clinicians diagnose a variety of conditions by providing detailed internal anatomical and functional imaging.

The FaceHeart Vitals Software Development Kit (FH vitals SDK) is an AI-based software that measures pulse rate from facial video streams using standard cameras on mobile devices or computers. It provides non-invasive, real-time pulse rate monitoring for adults at rest, intended to assist healthcare professionals but not to replace critical care or continuous monitoring. The SDK uses face recognition and signal processing algorithms to produce accurate pulse rate measurements, helping clinicians monitor patient heart rate remotely or in general healthcare settings.

The Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR is a 3 Tesla MRI system developed by Canon Medical Systems Corporation. It produces detailed cross-sectional images of the body and head using advanced AI-powered reconstruction techniques to enhance image quality, reduce artifacts, and improve workflow for clinicians. The device supports various deep learning-based features for motion correction, image resolution enhancement, noise reduction, and automated scan protocols, aiding diagnosis and patient care.

VisAble.IO is a software tool that helps doctors plan and confirm liver ablation procedures using CT images. It provides features like segmentation of liver structures, virtual placement of ablation needles, and analysis of ablation zones to support clinicians during treatment. It is designed to improve the accuracy and efficiency of liver ablation therapy planning and evaluation in clinical settings.

AIRAscore is an AI-powered software that automates the identification, labeling, and volumetric measurement of brain structures from MRI scans. It helps clinicians quickly obtain detailed brain volume information, which can aid in diagnosis and monitoring of neurological conditions by providing consistent and accurate brain segmentation results.

The Withings Scan Monitor 2.0 is a smart scale device that records a two-channel electrocardiogram (ECG) when a user stands on it and holds a handle. It analyzes the ECG data using AI algorithms to detect normal rhythms and atrial fibrillation, and displays results on the device and a mobile app, helping patients and clinicians monitor heart conditions conveniently at home or clinical settings.

qXR-PTX-PE is an AI-powered software that assists radiologists by automatically analyzing adult chest X-rays to detect signs of pleural effusion and pneumothorax. It helps prioritize cases by providing case-level outputs within the existing PACS/workstation without altering images or providing direct clinical diagnosis, thereby improving workflow efficiency.