DeepRhythmAI
Medicalgorithmics S.A.DeepRhythmAI is a cloud-based AI software that automatically analyzes two-lead ECG data to detect cardiac arrhythmias. It supports healthcare professionals by providing analysis results that need to be reviewed and confirmed. It is designed for integration into other medical devices or software platforms and assists clinicians in identifying rhythm issues in adult patients.
Intended Use
DeepRhythmAI is a cloud-based software for the assessment of cardiac arrhythmias using two lead ECG data in adult patients, intended for use by healthcare solution integrators to build applications allowing qualified healthcare professionals to review and confirm analytic results.
Technology
Software-only device utilizing a scalable Application Programming Interface (API) and a proprietary deep-learning algorithm to automatically detect cardiac beats, arrhythmias, and intervals from compatible ambulatory ECG recordings; designed for integration into other medical products without a primary user interface.
Performance
Performance testing was conducted following recognized standards ANSI/AAMI/IEC 60601-2-47:2012/(R)2016, AAMI/ANSI/EC57:2012, and FDA guidance on software validation. Testing showed the device meets intended use and is substantially equivalent to predicate devices, with no new safety or effectiveness issues.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/19/2021
1 year, 4 months - 2
FDA Approval
7/27/2022
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