FDA Radiology AI Devices

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.

Oxehealth Vital Signs is a software device that analyzes video images captured by standard cameras to noninvasively measure a patient's pulse rate and estimated breathing rate. It uses proprietary algorithms to monitor skin pixel intensity changes and chest wall movements, allowing healthcare staff to perform vital sign spot checks without disturbing the patient. This is especially useful in hospital or secured environments where minimizing patient contact is advantageous.

The Analytic for Hemodynamic Instability (AHI) is a software device that analyzes ECG signals to monitor patients' hemodynamic status, detecting signs of instability defined by low blood pressure combined with high heart rate. It provides clinicians with frequent, updated alerts to increase vigilance for patients at risk of hemodynamic deterioration, serving as an adjunctive monitoring tool alongside other patient data to improve early detection and patient management in clinical settings.

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.

The VX1 is a cardiac mapping software tool designed to assist clinicians during atrial fibrillation or atrial tachycardia procedures by analyzing 3D anatomical and electrical maps of the heart's atria. Using machine and deep learning algorithms, it identifies complex dispersed electrograms in real-time to help guide electrophysiologists in annotating areas of interest, potentially improving mapping accuracy during catheter ablation procedures.

AI-ECG Tracker is software designed to assist healthcare professionals in hospitals by automatically analyzing ambulatory ECG data to detect and assess cardiac arrhythmias in adults. It processes ECG waveforms, detects specific ECG features like QRS complexes and ectopic beats, measures intervals and heart rate, and provides advisory interpretations to support clinical diagnosis of arrhythmias, but not as the sole diagnostic tool.

The Study Watch with Irregular Pulse Monitor is a wearable device that records, stores, and transmits single-channel ECG rhythms to help detect irregular pulses such as atrial fibrillation in adults. It uses proprietary electrodes and PPG sensors to collect physiological data, which can be reviewed by healthcare professionals via a web portal to support diagnosis and patient monitoring.

The FFRangio System is a software tool that analyzes previously acquired angiographic images using 3D computer modeling to simulate blood flow in coronary arteries. It provides a mathematically derived value to support the functional assessment of coronary artery disease, helping clinicians evaluate artery physiology and make informed treatment decisions.