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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