FDA Radiology AI Devices

The Global Hypoperfusion Index (GHI) Algorithm is a software tool used on compatible advanced monitoring platforms to predict the risk of a global hypoperfusion event in surgical or non-surgical patients. It analyzes physiological data to provide clinicians with early warning of potential hemodynamic instability, helping to anticipate and manage patient deterioration in critical care settings.

The Saranas Early Bird Bleed Monitoring System is a single-use medical device designed to be inserted into the femoral artery or vein during endovascular procedures. It detects and monitors internal bleeding by measuring changes in bioimpedance, providing early indications of potential bleeding complications to physicians. This helps clinicians maintain patient safety by enabling early intervention during or after vascular interventions.

The ZEUS System by iRhythm Technologies is a software platform designed to analyze ECG data from wearable cardiac monitors to detect arrhythmias and other heart rhythm abnormalities. It uses AI algorithms to automatically process and identify cardiac events, assisting clinicians in diagnosing and managing heart conditions by generating detailed reports from long-term ECG recordings.

The VX1+ by Volta Medical is an advanced cardiac mapping system that uses machine learning to assist clinicians by automatically or manually annotating 3D anatomical and electrical maps of the heart's atria. It helps identify areas exhibiting complex electrical activity during arrhythmias such as atrial fibrillation, potentially aiding catheter ablation procedures.

The STAR Apollo Mapping System is a software tool designed to help physicians analyze detailed electrical and anatomical heart maps collected during cardiac procedures for atrial fibrillation. By processing data from mapping catheters and displaying key activation patterns in the atria, it provides supplementary information that may assist clinicians in identifying areas of irregular heart activation, although its clinical significance is not yet established.

DeepRhythmAI is a cloud-based AI software that automatically analyzes two-lead ECG data to detect cardiac arrhythmias. It supports healthcare professionals by providing analysis results that need to be reviewed and confirmed. It is designed for integration into other medical devices or software platforms and assists clinicians in identifying rhythm issues in adult patients.

The Study Watch with Irregular Pulse Monitor by Verily Life Sciences is a wearable device designed for adults diagnosed with or at risk for atrial fibrillation (AF). It continuously monitors heart rhythms using photoplethysmography (PPG) and single-channel ECG measurements. The device notifies users of irregular pulses, prompting ECG collection, and securely transmits data for healthcare provider review. This aids early detection and monitoring of AF, enabling timely clinical intervention.

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.

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.