FDA Radiology AI Devices

Salix Coronary Plaque (V1.0.0) is an AI-powered software designed to automatically process and analyze radiological images, specifically helping clinicians assess coronary artery plaques to improve cardiac care.

The BeneVision Central Monitoring System is a networked patient monitoring solution designed for use in professional healthcare settings. It enables clinicians to remotely view, store, and manage physiological data and alarms from various compatible monitors and anesthesia devices, including ECG and cardiac data. This system improves patient care by providing real-time and historical patient data access and supports alarm notifications to caregivers, enhancing clinical decision-making and patient safety.

The EnSite™ X EP System is a computerized diagnostic tool that helps visualize and map the electrical activity of the heart during electrophysiological procedures. It displays the 3D position of catheters inside the heart and creates detailed maps of cardiac chambers to aid clinicians in diagnosing and treating heart rhythm disorders.

Sleepiz One+ (2.5) is a contactless medical device that uses Doppler radar technology to measure heart rate and respiration rate in adult patients at rest or during sleep. It detects patient presence and body movements, allowing healthcare professionals to monitor these vital signs remotely either in clinical or home settings through cloud-based software. It aids clinicians by providing continuous non-contact monitoring without the need for wearable devices or electrodes.

The MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System is a wearable cardiac monitoring device for patients with suspected arrhythmias. It captures ECG data through a sensor pod with leads or a patch, which is wirelessly transmitted to a mobile gateway and then to a cloud-based software platform for analysis using proprietary algorithms. This helps physicians detect and monitor cardiac arrhythmias, aiding in diagnosis and treatment decisions without requiring patient intervention during use.

TINGSN FINDERS 2 is a color Doppler ultrasound system that helps clinicians visualize and assess blood flow and heart function using pulsed Doppler ultrasound technology. It assists in cardiovascular diagnosis by providing detailed images and flow information in real time.

HeartFlow Analysis is a software tool that uses advanced imaging and computational models to simulate coronary vascular physiology. It helps clinicians assess blood flow in the coronary arteries non-invasively, aiding in diagnosis and treatment planning for cardiac patients.

EchoPAC Software is a tool developed by GE Medical Systems that processes ultrasound images to assist clinicians in analyzing echocardiography data. It helps in improving workflow efficiency and accuracy in cardiac ultrasound interpretation.

HyperVue™ Software is an imaging system that uses Optical Coherence Tomography (OCT) technology to produce detailed images of cardiovascular structures. It helps clinicians by providing high-resolution images that assist in diagnosing and treating cardiovascular diseases.

Vivid Pioneer is an ultrasound imaging system using pulsed Doppler technology to help clinicians visualize and assess blood flow and cardiac function. It supports medical imaging and diagnosis, assisting healthcare professionals in evaluating patient health.