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.

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 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.

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.