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# Biofourmis RhythmAnalytics Arrhythmias Platform Cleared
- URL: https://www.fdaweb.com/biofourmis-rhythmanalytics-arrhythmias-platform-cleared/
- Published: 2019-04-29T12:00:00.000Z
- Updated: 2026-09-15T01:23:09.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143976

FDA has cleared a Biofourmis 510(k) for its RhythmAnalytics platform, a cloud-based software designed to automatically interpret cardiac arrhythmias. It uses an “enhanced deep-learning technique to detect over 15 types of cardiac arrhythmias along with beat-by-beat morphology computation which include ventricular arrhythmias, ventricular ectopic beats and all non-paced arrhythmias including Atrial Fibrillation (AFib),” the company says.

Data submitted to the agency demonstrated cardiologist-level arrhythmia detection and classification using its learning architecture, the company says. “Over 120,000 single-lead ECG episodes were used to train the neural network with over 30 distinctive cardiac arrhythmias,” it says, adding that RhythmAnalytics also outperformed two other similar deep learning systems.

The device supports analysis of electrocardiograms captured from any FDA-cleared devices or wearable sensors such as Holter monitors and event recorders, Biofourmis says. It can either be integrated as a cloud-based application programming interface into existing cardiac monitoring solutions or directly integrated into a medical device or wearable sensor, it adds.