FDA Radiology AI Devices

The Falcon/Xpress is a compact, portable ultrasonic diagnostic device designed for the noninvasive evaluation of peripheral vascular conditions. It uses pneumatic pressure measurements, Doppler ultrasound, and photo-plethysmography to assess blood flow and vascular health in various limb sites. This helps clinicians diagnose vascular diseases and monitor vascular function with specialized testing protocols.

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.

Laminar P1 is a wearable and disposable ultrasound patch sensor designed to detect blood flow in peripheral vessels to help identify peripheral vascular disease. It is intended for use by healthcare professionals in various settings and offers a compact alternative to traditional Doppler ultrasound probes, providing audio output and selectable sensitivity settings to aid clinical assessments.

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.

EchoGo Amyloidosis (1.0) is an automated AI decision support system that analyzes 2D echocardiograms (specifically apical four chamber view) to screen for cardiac amyloidosis in adults over 65 years with heart failure. It helps clinicians by classifying patients as suggestive or not suggestive of cardiac amyloidosis, enabling referral for confirmatory testing. The AI was trained on large datasets and validated clinically to ensure accuracy and safety.

The UbiqVue 2A Multi-parameter System is a wireless wearable biosensor system for continuous monitoring of vital signs such as ECG, heart rate, respiration, temperature, SpO2, and blood pressure (optional). It transmits data wirelessly to a central server for storage, display, and analysis, enabling healthcare professionals to remotely monitor multiple patients at home and in clinical settings with alert notifications and visual alarms for abnormal physiologic parameters.

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.