Zio vs KATE

The Zio service from iRhythm has 18 FDA 510(k) decisions, the newest ZEUS Platform K252859 on May 29, 2026, and an FDA warning letter dated May 25, 2023. The company's annual report says FDA issues remain open and that a further warning letter is possible. A deep neural network reads the patch data, technicians review it, and a physician report follows. iRhythm is public, with about 2,400 employees at the end of 2025, and bills payers through Medicare-enrolled IDTFs.

KATE from Mednition recommends triage acuity for emergency nurses and flags sepsis risk from EHR data at triage. A 2019 vendor release claimed triage accuracy up 26.9% at Adventist Health White Memorial. KATE Sepsis received Breakthrough Device Designation in November 2023, which is a designation and not a clearance, and openFDA lists no K or DEN number for it. Mednition's $10M Series A dates from 2019, and its site offers an ROI calculator instead of a price.

Zio is ordered by practices and health systems for ambulatory ECG monitoring. KATE is adopted by an emergency department for triage and sepsis flagging. The two have no buyer in common.