FDA Radiology AI Devices

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.

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 Empatica Health Monitoring Platform is a wearable device system that monitors various physiological parameters such as pulse rate, respiratory rate, oxygen saturation, and skin temperature by collecting sensor data, which is analyzed using AI algorithms. It enables healthcare professionals to review patients' physiological data remotely and retrospectively to assess their condition, improving patient monitoring in home healthcare settings.

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.

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.

InVision Precision Cardiac Amyloid is a software tool that uses machine learning to analyze echocardiogram videos and identify signs of cardiac amyloidosis in patients aged 65 and older. It integrates with existing hospital imaging systems and helps physicians screen patients by providing decision support alerts to guide referrals for further confirmatory tests.

VitalRhythm is a cloud-based AI software that continuously analyzes ECG signals to detect various cardiac arrhythmias. It works with a wearable biosensor (VitalPatch) and displays results to healthcare professionals for non-urgent clinical decision-making in outpatient and non-critical care settings. It helps clinicians monitor heart rhythms remotely and efficiently, assisting in diagnosis without replacing clinical judgment.

The WHOOP ECG (electrocardiogram) Feature is a mobile application software used with the WHOOP Strap wearable device to record and analyze a single-channel ECG signal similar to a Lead I ECG. It helps users detect atrial fibrillation, normal sinus rhythm, and abnormal heart rates by providing informational ECG data and rhythm classification, aiding users and clinicians in heart rhythm monitoring without replacing traditional diagnosis methods.

Masimo W1 is a wearable watch device that continuously records, displays, and transfers single-channel ECG rhythms and pulse oximetry parameters. It includes software for automated classification of atrial fibrillation to aid in heart rhythm identification, designed for adults in clinical and home settings to support healthcare professionals and patients in monitoring heart conditions.

The Pilot TLS system helps healthcare providers accurately position central venous catheters by real-time monitoring of the patient's cardiac electrical signals. This serves as an alternative to traditional chest X-ray or fluoroscopy confirmation methods, potentially reducing radiation exposure and speeding up catheter placement.