DeepRhythmAI
Medicalgorithmics S.A.DeepRhythmAI is a cloud-based AI software that automatically analyzes ECG data from one or two leads to detect cardiac arrhythmias. It supports integration with various ECG recording devices and systems, providing clinicians with supportive analysis to aid in diagnosis, improving cardiac rhythm assessment accessibility and efficiency.
Intended Use
DeepRhythmAI is a cloud-based software that utilizes AI algorithms to assess cardiac arrhythmias using a single- or two-lead ECG data from adult patients. It is intended for use by healthcare solution integrators to build applications that allow qualified healthcare professionals to review and confirm analytic results. Supports data from Holter, Event recorders, Outpatient Cardiac Telemetry, and other similar devices.
Technology
DeepRhythmAI uses convolutional neural networks (CNN) and transformer AI models as an automated proprietary deep-learning algorithm to measure and analyze ECG data. It operates as a cloud-based software with a scalable application programming interface (API) for integration with other medical products and does not include a native user interface.
Performance
Performance testing followed international consensus standards ANSI/AAMI EC57:2012 and ANSI/AAMI/IEC 60601-2-47:2012/(R)2016, validated using a proprietary database representing the intended patient population, including two-lead and single-lead patch recorder data. Software verification and validation met all requirements with no residual anomalies, and cybersecurity tests showed no vulnerabilities.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/28/2025
2 months - 2
FDA Approval
5/27/2025
Other devices from Medicalgorithmics S.A.
- DeepRhythmAI2024 • 510K
- DeepRhythmAI2022 • 510K
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