PhysCade System
PhysCade, Inc.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. This assists physicians to make more informed clinical decisions during electrophysiology procedures, improving patient care for those with heart rhythm disorders.
Intended Use
The PhysCade System is intended for the analysis, display, and storage of cardiac electrophysiological data and maps for analysis by a physician.
Technology
The system is an AI-enabled diagnostic tool that post-processes electrograms collected from compatible multi-electrode cardiac catheters during electrophysiology mapping procedures. It provides outputs including earliest activation sites, activation times, voltage, and signal quality via proprietary software on a computer workstation. It operates independently of other medical devices in the cardiac electrophysiology lab outside the sterile field.
Performance
The PhysCade System underwent extensive non-clinical testing including software verification and validation, hardware performance testing, AI/ML accuracy validation, and usability testing. It complies with IEC 62304 standards and relevant FDA cybersecurity and software guidance documents, demonstrating safety and effectiveness for its intended use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/12/2025
2 months - 2
FDA Approval
6/4/2025
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