FDA Radiology AI Devices

The VeriSight Intracardiac Echocardiography Catheters (VSICE2D and VSICE3D) are disposable devices used during cardiac procedures to provide real-time ultrasound imaging inside the heart and nearby vessels. They help clinicians visualize cardiac anatomy and physiology in both adult and pediatric patients for guidance during interventions, improving the accuracy and safety of heart treatments.

The Volta AF-Xplorer is a medical device that uses machine and deep learning algorithms to help clinicians annotate 3D anatomical and electrical maps of the human heart in real-time. It primarily assists in identifying regions within the atria that exhibit abnormal electrical activity during atrial fibrillation or atrial tachycardia, which can guide targeted catheter ablation procedures, improving patient outcomes.

The AT-Patch (ATP-C130/ATP-C70) is a wearable ECG monitoring device that records cardiac electrical activity for up to 14 or 7 days respectively. It collects ECG data from a patch worn on the patient's torso, which is then analyzed by software algorithms to detect arrhythmias and other cardiac events. A physician reviews this analysis to provide a report to help clinicians diagnose heart conditions, aiding in the management of symptoms like palpitations, dizziness, and fatigue.

VitalRhythm is a cloud-based AI software that continuously analyzes ECG signals to detect various cardiac arrhythmias. It works with a wearable biosensor (VitalPatch) and displays results to healthcare professionals for non-urgent clinical decision-making in outpatient and non-critical care settings. It helps clinicians monitor heart rhythms remotely and efficiently, assisting in diagnosis without replacing clinical judgment.

The Cornaris Intravascular Imaging System (P80-E and Mobile-E) with the LumenCross Imaging Catheter (F2) is an advanced intravascular imaging system designed to help clinicians visualize coronary arteries during transluminal interventional procedures. It uses optical coherence tomography technology to provide high-resolution images of the inside of blood vessels, aiding in diagnosis and treatment planning for patients with coronary artery conditions. The system enhances the ability to assess blood vessels safely and effectively, improving patient outcomes.

The WHOOP ECG (electrocardiogram) Feature is a mobile application software used with the WHOOP Strap wearable device to record and analyze a single-channel ECG signal similar to a Lead I ECG. It helps users detect atrial fibrillation, normal sinus rhythm, and abnormal heart rates by providing informational ECG data and rhythm classification, aiding users and clinicians in heart rhythm monitoring without replacing traditional diagnosis methods.

Masimo W1 is a wearable watch device that continuously records, displays, and transfers single-channel ECG rhythms and pulse oximetry parameters. It includes software for automated classification of atrial fibrillation to aid in heart rhythm identification, designed for adults in clinical and home settings to support healthcare professionals and patients in monitoring heart conditions.

The VERAFEYE System by Luma Vision Limited is an advanced ultrasound imaging tool designed for real-time visualization inside the heart and great vessels during cardiac procedures. It includes a sterile catheter and an imaging console that creates 2D and 3D ultrasound images to help clinicians see cardiac anatomy and physiology, guiding interventions safely and accurately.

The Philips Holter Analysis System is a standalone software designed to analyze ambulatory ECG recordings collected over extended periods (typically 24 hours to 7 days). It automatically processes ECG data to detect heart rhythm disturbances, arrhythmias, pacemaker function, and myocardial ischemia-related symptoms, providing reports to assist clinicians in evaluating cardiac health. The system enhances arrhythmia detection algorithms and heart rate variability analysis and integrates with clinical information systems for streamlined ECG data management.

The Starlight Imaging Catheter is a sterile, single-use catheter designed for imaging coronary arteries in patients undergoing transluminal interventional procedures. It uses near-infrared light and an internal rotating fiber optic core to capture detailed cross-sectional images inside vessels, helping clinicians assess vessel condition and guide interventions safely and effectively.