FDA Radiology AI Devices

Viz HCM is a machine learning-based software designed to analyze 12-lead ECG recordings to detect signs of hypertrophic cardiomyopathy (HCM). It helps clinicians identify patients who may have HCM and need further clinical follow-up, supporting early detection though not replacing full diagnostic evaluation. The system includes an ECG analysis algorithm and a mobile app to present results, improving screening in routine cardiology care.

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.

AusculThing ACC is an AI-powered decision support software that analyzes heart sounds recorded by an electronic stethoscope to help healthcare providers distinguish between normal and abnormal heart murmurs. It provides instant, automated analysis and visual and acoustic feedback to support clinical evaluation in both adult and pediatric patients.

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 ZEUS System (Zio Watch) is a prescription-based wearable device and software system that uses AI to analyze cardiac signals from an ECG and PPG sensor to detect and report atrial fibrillation. It provides clinicians with detailed reports to aid in diagnosing and managing atrial fibrillation 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.