Digital health company snags FDA clearance for atrial fibrillation algorithm

Cardiac-focused digital health company iRhythm has received FDA 510(k) clearance for an algorithm that monitors atrial fibrillation and will be paired with wearable technology.

The Zio ECG Utilization Software, or Zeus, system is an artificial intelligence algorithm that detects Afib and calculates an Afib burden estimate. The Zeus system can then send a report to a clinician, according to a July 22 press release.

The Zeus system algorithm will be paired with the Zio watch, the wearable component of the system, which was created through a partnership between iRhythm and Verily, an Alphabet company. The Zio watch also received FDA 510(k) clearance, according to the press release.

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