Eko Health vs Zio

Eko's openFDA record shows 10 clearances, all 510(k), the newest K261694 for the CORE 300 stethoscope on July 23, 2026. iRhythm's shows 18, the newest K252859 for the ZEUS Platform on May 29, 2026. iRhythm also received an FDA warning letter on May 25, 2023 over a Zio AT change made without clearance, and its FY2025 10-K says FDA issues remain open and a further warning letter, consent decree or recall is possible. For a health system whose vendor review screens out unresolved FDA issues, iRhythm is the weaker pick.

A cardiology group that wants a rhythm check at the visit buys Eko, where AFib detection runs on the CORE 500 and the AI sits behind the Eko+ membership at $119.99 per year. A group that sends patients home with an ECG patch buys iRhythm. It sells a service that bundles the patch, deep-learning analysis, technician review and a physician report, billed to payers through Medicare-enrolled IDTFs, with no public price.