PhysCade System
Overview
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, assisting physicians in making more informed clinical decisions during electrophysiology procedures, and improving patient care for those with heart rhythm disorders. It functions as an AI-enabled medical decision support system that post-processes electrograms (EGMs) collected inside the heart during electrophysiology (EP) mapping procedures using compatible diagnostic EP catheters. The system comprises a computer workstation, display, and custom software, and is intended to be used in the cardiac electrophysiology lab, outside the sterile field, operating independently of other medical devices.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-driven analysis of intra-cardiac electrophysiological data
- Visualization of detailed maps identifying early activation sites
- Assists in identifying features of interest in the heart during arrhythmia procedures
- Post-processes electrograms (EGMs) from compatible diagnostic EP catheters
- Provides specialized analyses including predominant earliest site of activation (coPILOT)
- Determines activation times of successive beats (coMAP)
- Measures voltage at each electrode and signal quality
- Analyzes sequences of propagation over multiple beats of the arrhythmia
- Operates as a computer workstation with custom software
- Intended for use in the cardiac electrophysiology lab, outside the sterile field
Use Cases
- Assisting clinicians in managing patients with heart rhythm disorders (arrhythmias)
- Supporting clinical decisions during electrophysiology procedures
- Analyzing and visualizing intra-cardiac electrophysiological data
- Identifying early activation sites during atrial arrhythmias
- Guiding electrophysiology catheters during atrial fibrillation ablation
What Physicians Need to Know
Physicians should recognize PhysCade as a specialized AI-driven tool for analyzing cardiac electrophysiological data to assist in the management of heart rhythm disorders. It provides detailed information on regions of interest and earliest activation sites, which can support clinical decision-making during EP procedures. It's crucial to integrate this information with comprehensive patient data and clinical judgment, especially given that its clinical significance for identifying specific features during atrial arrhythmias has not been fully established by clinical investigations. Ensure personnel operating the system are adequately trained.
The PhysCade System operates as a standalone computer workstation with custom software. It is not designed to be connected to other medical devices or equipment, functioning independently within the cardiac electrophysiology lab. Its output is intended to be used by clinicians in conjunction with other available patient-related information.
Details
| Category | Cardiology AI |
| Pricing | Unknown |
| Deployment | On-premise (computer workstation in cardiac electrophysiology lab) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated The PhysCade System received FDA approval on June 4, 2025, under submission number K250749. It is an AI-enabled device intended to assist clinicians in the management of patients with heart rhythm disorders (arrhythmias). |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology |
What the Web Says
The PhysCade System is a medical device intended for the analysis, display, and storage of cardiac electrophysiological data and maps for analysis by a physician. It utilizes advanced algorithms to analyze collected electrograms (EGMs) to identify regions of interest in the heart, which can support clinical decisions. The system received FDA 510(k) clearance in June 2025.
Overall: PositiveStrengths
- Analyzes and visualizes intra-cardiac electrophysiological data.
- Assists physicians in identifying areas with early activated potentials and other features during atrial arrhythmias.
- Utilizes advanced algorithms to provide information on regions of interest in the heart.
- Intended to support clinical decisions.
- Underwent extensive non-clinical testing, including software/firmware, cybersecurity, design verification, design validation (for AI/ML accuracy), and usability testing.
- Received FDA 510(k) clearance.
Limitations
- The clinical significance of using the system to identify specific features during atrial arrhythmias has not been established by clinical investigations.
Based on reviews from: N1 Health, accessdata.fda.gov, Innolitics
Last updated: 2026-07-19
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