FDA Radiology AI Devices

BrightHeart View Classifier is a cloud-based AI-powered software designed to analyze 2D fetal ultrasound images and video clips to automatically identify and classify standard fetal heart views. It assists trained healthcare professionals in acquiring and interpreting fetal heart ultrasound exams in the second and third trimesters by providing annotated outputs and validating whether scanning protocols are met, improving diagnostic workflow and consistency.

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.

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.

The EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound System by Philips Ultrasound LLC are advanced ultrasound systems designed for diagnostic imaging and fluid flow analysis across multiple body regions. They include an AI software feature called R-Trigger that detects R-wave peaks from cardiac cycles without requiring ECG input, aiding automated cardiac measurements to simplify and improve workflow for clinicians during transthoracic echo exams.

The iBSM is a wireless patient monitoring system designed for hospital use on non-critical patients aged 18 and older. It continuously displays vital signs such as ECG waveforms, heart rate, respiratory rate, oxygen saturation, and blood pressure using biocompatible sensors. It aids clinicians by providing real-time physiological data, visual and audio alarms, and patient orientation notifications to help prevent complications like pressure ulcers.

The Volta AF-Xplorer is a medical device that uses machine and deep learning algorithms to help clinicians annotate 3D anatomical and electrical maps of the human heart in real-time. It primarily assists in identifying regions within the atria that exhibit abnormal electrical activity during atrial fibrillation or atrial tachycardia, which can guide targeted catheter ablation procedures, improving patient outcomes.

The EPIQ and Affiniti Series Diagnostic Ultrasound Systems by Philips Ultrasound LLC provide advanced ultrasound imaging and fluid flow analysis for various body regions, including cardiac adult imaging. These systems incorporate AI-driven software features such as Segmental Wall Motion Version 2 (SWM v2) and Auto EF with contrast, which assist clinicians in automating the evaluation of left ventricular function and ejection fraction using transthoracic echocardiography. This helps healthcare providers make more accurate and efficient cardiac assessments during diagnostic imaging.