FDA Radiology AI Devices

Oxehealth Vital Signs is a software medical device that uses video footage from fixed-installation cameras to noninvasively measure pulse rate and estimated breathing rate through analysis of chest wall movements. It is designed for use in single occupancy rooms within hospitals and secured environments where healthcare professionals periodically monitor patients. This technology enables spot checks of vital signs without physical contact, supporting clinical monitoring while minimizing patient disturbance and infection risk.

DEEPVESSEL FFR is a clinical software tool that uses deep learning to analyze previously acquired coronary CT angiography (CTA) images. It generates three-dimensional models of coronary artery trees and estimates fractional flow reserve (FFR) values to help clinicians assess the functional severity of coronary artery disease. It supports doctors by providing additional insight beyond anatomical imaging, using AI-based physiological simulation to improve diagnosis and treatment planning for heart vessel conditions.

The AHI System is a software tool that helps healthcare professionals monitor adult patients' cardiovascular status by analyzing ECG signals to detect signs of current hemodynamic instability and predict future episodes. It provides continuous updates and color-coded alerts for clinicians to increase vigilance and improve patient care.

IM007 by Implicity, Inc. is an AI-powered software that analyzes ECG data from Insertable Cardiac Monitors to help healthcare professionals detect various cardiac arrhythmias, such as atrial fibrillation and ventricular tachycardia. It works by processing ECG signals remotely uploaded from compatible devices and provides analysis results to clinicians to support diagnosis and patient monitoring.

The Irregular Rhythm Notification Feature 2.0 (IRNF 2.0) is a software application used on Apple Watch and iPhone that analyzes pulse rate data using machine learning to detect irregular heart rhythms, such as atrial fibrillation (AFib). It notifies users of possible AFib episodes to help prompt medical consultation, supporting non-invasive heart rhythm monitoring through wearable technology.

Oxehealth Vital Signs is a software device that uses optical cameras to noninvasively measure pulse rate and estimated breathing rate from video footage of patients. It facilitates vital sign monitoring in single-occupancy hospital rooms and care environments without physical contact, helping clinicians monitor patients effectively, especially those who do not require critical or continuous monitoring.

The OPTIS Mobile Next Imaging System and OPTIS Integrated Next Imaging System by Abbott Medical are advanced OCT imaging systems designed for use in cardiovascular catheterization labs. Paired with compatible Dragonfly imaging catheters, these devices provide detailed imaging of coronary arteries and physiological measurements to help physicians assess coronary lesions and determine the need for intervention.

The Zio ECG Utilization Software (ZEUS) System is a software platform that processes and analyzes long-term continuous ECG data collected from compatible cardiac monitoring devices. It helps clinicians by automatically detecting and reporting cardiac arrhythmias and other relevant heart rhythm information, assisting in the diagnosis and management of cardiac conditions.

HeartFlow Analysis is a medical software that uses previously acquired coronary CT images to create 3D models and simulate blood flow dynamics in coronary arteries. It helps clinicians assess coronary artery disease by providing detailed functional information derived mathematically from CT scans, supporting diagnosis and treatment planning in stable symptomatic patients.

The Stethee Pro 1 is an electronic stethoscope designed for medical screening and diagnostic use. It detects and amplifies sounds from the heart, lungs, and other internal organs, and works with the Stethee Pro Software System to record, visualize, analyze, and share these sounds. This helps clinicians better assess patient heart and lung conditions through enhanced audio and data analysis tools.