FDA Radiology AI Devices

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 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.

The Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter is a reprocessed ultrasound catheter designed for imaging inside the heart and great vessels of adult patients. It assists clinicians by providing intracardiac and intraluminal visualization using the ultrasound modality. The catheter is intended for imaging guidance during cardiac interventional procedures, improving visualization of cardiac anatomy and device placement without treatment delivery.

The Makoto Intravascular Imaging System™ is a medical imaging device that uses near-infrared spectroscopy combined with intravascular ultrasound to examine coronary and peripheral arteries. It helps clinicians detect lipid-core plaques, assess coronary artery lipid burden, and identify patients at risk of cardiac events by providing detailed images and compositional information of blood vessels. The device includes software that automatically identifies vessel borders and guide catheter locations, aiding in precise and efficient vascular assessment during invasive angiographic procedures.

The Etiometry Platform is a software solution designed for use in intensive care settings to help healthcare professionals monitor and assess cardiovascular and respiratory conditions in adult, pediatric, and neonatal patients. It collects real-time physiological and laboratory data remotely from various bedside devices, displays this data, and calculates risk indices like oxygen delivery adequacy and ventilation status. This assists clinicians in timely clinical decision-making without requiring new hardware.

The Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter is a medical imaging device designed to provide high-resolution, real-time images of coronary arteries in patients undergoing transluminal interventional procedures. It uses near-infrared light delivered via a fiber-optic catheter to visualize coronary tissue, aiding clinicians in diagnosis and treatment planning.