FDA Radiology AI Devices

The OPUSWAVE Dual Sensor Imaging System is a medical device that uses Optical Coherence Tomography to capture detailed images of cardiovascular structures. It helps clinicians by providing high-resolution imaging to assist in diagnosis and treatment of cardiovascular conditions.

EchoGo Amyloidosis (1.0) is an automated AI decision support system that analyzes 2D echocardiograms (specifically apical four chamber view) to screen for cardiac amyloidosis in adults over 65 years with heart failure. It helps clinicians by classifying patients as suggestive or not suggestive of cardiac amyloidosis, enabling referral for confirmatory testing. The AI was trained on large datasets and validated clinically to ensure accuracy and safety.

Frontier X Plus is a wearable ECG event recorder that monitors heart rhythms by capturing single-channel ECG signals via a chest strap. It automatically analyzes the ECG data using an embedded algorithm to detect arrhythmias such as atrial fibrillation, bradycardia, and tachycardia. The device helps clinicians monitor and diagnose heart conditions in adult patients, particularly those with suspected or known cardiac issues, by storing and transferring ECG data for physician review.

The Affera Integrated Mapping System with the Impedance Localization Patch Kit is a computer-based diagnostic tool designed to assist clinicians in catheter-based cardiac electrophysiological mapping. It provides real-time visualization of catheters, maps cardiac signals, and helps guide therapeutic interventions by displaying detailed cardiac maps and signals, enhancing cardiac procedure accuracy and patient care.

The ShortCut device by Pi-Cardia Ltd. is a single-use catheter designed to safely split bioprosthetic aortic valve leaflets to facilitate valve-in-valve procedures in patients at risk of coronary obstruction. This catheter-based tool is inserted via the femoral artery and positions its distal cutting element on valve leaflets to perform precise cuts, helping improve blood flow and reduce complications during transcatheter valve replacement procedures. It has been demonstrated in clinical studies to be effective and safe, providing a new treatment option for high-risk patients undergoing valve-in-valve procedures.

EchoGo Heart Failure 2.0 is an AI-powered software tool that analyzes echocardiogram images of the heart's apical four-chamber view to support clinicians in detecting heart failure with preserved ejection fraction (HFpEF). It provides a diagnostic aid by outputting a classification and a confidence score, enhancing cardiovascular assessments and helping guide clinical decision-making.

HeartKey Rhythm is a software platform designed to analyze ECG data from various ambulatory monitoring devices such as Holters and ECG patches. Using a combination of machine learning and signal processing, the software detects heartbeats, assesses rhythm, and identifies arrhythmias to assist healthcare professionals in diagnosing cardiac conditions. It integrates through an API into other ECG management or monitoring systems and supports non-urgent clinical decision making.

Tempus ECG-AF is an AI-powered software that analyzes standard 12-lead ECG recordings from patients aged 65 and older to detect signs indicating an increased risk of atrial fibrillation or atrial flutter within the next 12 months. It assists clinicians by providing risk notifications based on ECG data, improving early identification of patients who may require further diagnostic follow-up.

Corvair is an AI-powered software that analyzes resting ECG recordings to detect various heart rhythms, morphological abnormalities, and measure ECG intervals. It supports healthcare professionals by providing an initial automated interpretation of ECGs to assist in cardiac diagnosis, enhancing accuracy and efficiency in clinical settings.

The CorVista System with PH Add-On is a non-invasive AI-based medical device that analyzes sensor-acquired cardiac electrical and hemodynamic signals to indicate the likelihood of elevated pulmonary arterial pressure, aiding clinicians in diagnosing pulmonary hypertension. It provides results through a user-friendly digital interface and supports healthcare providers by combining the AI output with clinical judgment.