FDA Radiology AI Devices

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 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 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.

Viz HCM is a machine learning-based software designed to analyze 12-lead ECG recordings to detect signs of hypertrophic cardiomyopathy (HCM). It helps clinicians identify patients who may have HCM and need further clinical follow-up, supporting early detection though not replacing full diagnostic evaluation. The system includes an ECG analysis algorithm and a mobile app to present results, improving screening in routine cardiology care.

The Global Hypoperfusion Index (GHI) Algorithm is a software tool used on compatible advanced monitoring platforms to predict the risk of a global hypoperfusion event in surgical or non-surgical patients. It analyzes physiological data to provide clinicians with early warning of potential hemodynamic instability, helping to anticipate and manage patient deterioration in critical care settings.

UltraSight AI Guidance is a mobile AI-based application that helps non-expert medical professionals acquire high-quality cardiac ultrasound images by providing real-time guidance on how to position and manipulate the ultrasound probe for standard transthoracic echocardiography views. It enhances image acquisition quality and enables better diagnosis even by novice users.

AusculThing ACC is an AI-powered decision support software that analyzes heart sounds recorded by an electronic stethoscope to help healthcare providers distinguish between normal and abnormal heart murmurs. It provides instant, automated analysis and visual and acoustic feedback to support clinical evaluation in both adult and pediatric patients.

CAC Software by Imbio, Inc. is a machine learning-based post-processing tool that analyzes non-contrast CT images of the chest to assess calcified plaques in the coronary arteries. It quantifies the calcification burden by producing scores and metrics that help clinicians evaluate coronary artery disease risk. The software outputs annotated images and a detailed report, integrating into the standard DICOM workflow to assist physicians without making standalone diagnoses.

FEops HEARTguide™ ALPACA is an AI-enabled medical imaging software system that helps clinicians visualize and measure detailed heart and vessel structures from CT images. It aids in planning minimally invasive heart procedures by providing automated segmentation, 3D visualization, measuring tools, and reporting. This software supports better procedural decisions by combining anatomical insights with clinical evaluation.

Sonic DL is a software feature by GE Healthcare that uses deep learning to reconstruct cardiac MR images much faster by processing under-sampled data. It allows highly accelerated imaging with preserved image quality, enabling faster and more efficient MRI scans for cardiac assessment in patients of all ages.