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.

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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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