Zio vs PaceMate

PaceMate's homepage describes bi-directional integration with Epic, Oracle Health and athenahealth, and Auto-Triage ranks device alerts by clinical priority. The vendor claims a 61% reduction in physician alert burden, and its security page states HITRUST r2 and SOC 2 Type 2 with a BAA available. The pricing page shows Software, Flexible, Premium and Elite tiers without amounts. OpenFDA returns no 510(k) under the PaceMate applicant name, and the pages read make no regulatory statement. It is built for device clinics working through pacemaker alert queues.

iRhythm sells ambulatory ECG monitoring as one service made of the Zio patch, cloud analysis, technician review and a physician report, and openFDA lists 18 of its 510(k) records, the latest the ZEUS Platform, K252859, in May 2026. An FDA warning letter on May 25, 2023 said the Zio AT had been changed without clearance and marketed to a new high-risk population. A Form 483 followed inspections in July 2024, and two Zio AT 510(k)s were cleared that October. The company's FY2025 10-K says FDA issues remain open.

A practice ordering ambulatory ECG monitoring is iRhythm's customer, and a device clinic is PaceMate's.