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.

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.

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 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.

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.

The PhysCade System is a specialized AI-driven software and hardware platform designed to analyze and visualize intra-cardiac electrophysiological data collected during heart rhythm studies. It helps clinicians by providing detailed maps identifying early activation sites and other features of interest in the heart during arrhythmia procedures. This assists physicians to make more informed clinical decisions during electrophysiology procedures, improving patient care for those with heart rhythm disorders.

Radius VSM and Accessories is a wearable multi-parameter patient monitor from Masimo Corporation designed for continuous monitoring of vital signs like heart rhythm, blood pressure, oxygen saturation, respiratory rate, and skin temperature. It helps clinicians monitor patients' cardiovascular and respiratory status in hospital settings and includes arrhythmia detection, facilitating timely clinical intervention and patient management.

The OptiMap™ System is a medical device used during electrophysiology procedures to help physicians analyze and visualize complex cardiac arrhythmias. It uses a 64-electrode basket catheter to capture electrogram signals within the heart, which are processed with proprietary algorithms to create detailed maps of electrical flow and activation pathways. This assists clinicians in diagnosing and understanding heart rhythm disorders more effectively.

DeepRhythmAI is a cloud-based AI software that automatically analyzes ECG data from one or two leads to detect cardiac arrhythmias. It supports integration with various ECG recording devices and systems, providing clinicians with supportive analysis to aid in diagnosis, improving cardiac rhythm assessment accessibility and efficiency.