FDA Radiology AI Devices

The Affera Integrated Mapping System is a software and hardware system designed to help cardiologists map the heart's electrical activity during catheter-based procedures. It uses magnetic and electromagnetic tracking to visualize catheters inside the heart in real time, records electrical signals from the heart, and displays 3D cardiac maps. This assists clinicians in diagnosing and treating heart rhythm disorders with improved accuracy and guidance.

PanopticAI Vital Signs is a medical software application that uses AI algorithms to measure pulse rate non-invasively by analyzing color changes in facial video captured from an iPhone or iPad camera. It helps healthcare professionals monitor a patient's pulse rate remotely, providing a convenient tool to complement traditional vital sign assessments.

The Cardiac Workstation 5000 and 7000 by Philips Medizin Systeme Böblingen GmbH are advanced electrocardiograph devices designed for healthcare professionals to acquire, analyze, and store multi-channel ECG signals from adult and pediatric patients. These devices use clinically proven algorithms to provide measurements, graphical presentations, and interpretive statements to support clinical decision-making in hospitals and cardiology clinics.

Mac-Lab (AltiX AI.i), CardioLab (AltiX AI.i), ComboLab (AltiX AI.i), and MLCL Client Software (AltiX AI.i) are hemodynamic and electrophysiology recording systems developed by GE Healthcare. These systems record and display physiological data during cardiovascular procedures, allowing clinicians to analyze hemodynamic and electrophysiology signals in real time. The MLCL Client Software allows additional data analysis and remote viewing. These tools help doctors monitor and analyze patients' cardiovascular function during interventional procedures.

The HemoSphere Alta Advanced Monitoring Platform is an advanced medical monitoring system used primarily in critical care for adult and pediatric patients. It combines data from various catheters and sensors to continuously measure cardiac output, pressures, blood oxygenation, and derived hemodynamic parameters. The system provides clinicians with insights about cardiac function and patient status through integrated algorithms and a user-friendly interface, supporting decision-making in complex clinical scenarios.

The Magnetic Localization Patch Kit by Medtronic is an accessory device used with the Affera Integrated Mapping System to accurately track and navigate catheters during cardiac electrophysiology procedures. It uses electromagnetic-based tracking technology to provide real-time catheter localization and cardiac mapping, helping clinicians perform heart rhythm diagnoses and treatments more precisely.

DeepRhythmAI is a cloud-based AI software that analyzes two-lead ECG data to detect cardiac arrhythmias in adult patients. It integrates with ambulatory ECG devices like Holter monitors and cardiac telemetry systems to help healthcare professionals review and confirm arrhythmia diagnoses, providing supportive information alongside clinical knowledge.

Frontier X Plus is a wearable ECG event recorder that monitors heart rhythms by capturing single-channel ECG signals via a chest strap. It automatically analyzes the ECG data using an embedded algorithm to detect arrhythmias such as atrial fibrillation, bradycardia, and tachycardia. The device helps clinicians monitor and diagnose heart conditions in adult patients, particularly those with suspected or known cardiac issues, by storing and transferring ECG data for physician review.

The Affera Integrated Mapping System with the Impedance Localization Patch Kit is a computer-based diagnostic tool designed to assist clinicians in catheter-based cardiac electrophysiological mapping. It provides real-time visualization of catheters, maps cardiac signals, and helps guide therapeutic interventions by displaying detailed cardiac maps and signals, enhancing cardiac procedure accuracy and patient care.

HeartKey Rhythm is a software platform designed to analyze ECG data from various ambulatory monitoring devices such as Holters and ECG patches. Using a combination of machine learning and signal processing, the software detects heartbeats, assesses rhythm, and identifies arrhythmias to assist healthcare professionals in diagnosing cardiac conditions. It integrates through an API into other ECG management or monitoring systems and supports non-urgent clinical decision making.