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Intended Use

DeepRhythmAI is a cloud-based software for the assessment of cardiac arrhythmias using two lead ECG data in adult patients. It is intended for use by healthcare solution integrators to build applications enabling qualified healthcare professionals to review and confirm analytic results. The product supports data from ambulatory ECG devices such as Holter monitors, event recorders, and outpatient cardiac telemetry. Interpretation results are advisory and not the sole means of diagnosis.

Technology

The software is cloud-based and uses a scalable API for integration. Its core component is an automated proprietary deep-learning algorithm that measures and analyzes ECG data to provide supportive information for healthcare professionals. It lacks a user interface, relying on integration with external visualization software for ECG review and reporting.

Performance

The algorithm underwent performance evaluation according to recognized consensus standards ANSI/AAMI EC57:2012 and ANSI/AAMI/IEC 60601-2-47:2012/(R)2016. Testing included validation against a proprietary database with a large number of relevant patient ECG recordings to ensure accuracy and robustness. The software development followed ANSI/AAMI/IEC 62304 and FDA guidance for software validation. Testing confirmed it meets intended use safely and effectively.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    4/30/2024

    7 months
  • 2

    FDA Approval

    12/4/2024

Other devices from Medicalgorithmics S.A.

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