FDA Radiology AI Devices

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.

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.

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.

The Globe Pulsed Field System is a catheter-based system designed for cardiac anatomical and electrophysiological mapping and stimulation. It helps clinicians visualize and assess electrical activity in the heart to diagnose and treat cardiac conditions more effectively by creating detailed 3D electroanatomical maps and guiding stimulation therapy.

Us2.ca is a clinical decision support tool that automatically analyzes echocardiogram images to assist cardiologists and healthcare professionals in identifying patients with potential cardiac amyloidosis. It improves clinical workflow by providing AI-derived measurements and report generation, helping clinicians focus on cases needing further follow-up, but it does not replace a formal diagnosis or current care standards.

The VitalSigns 1-Lead Holter (VSH101) is a wireless, ambulatory ECG monitoring device that records, transmits, and stores single-channel ECG data via Bluetooth to a compatible mobile app. It helps healthcare professionals and individuals with cardiac conditions by providing supplementary ECG information for patient monitoring.