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ZI

Zio

by iRhythm Technologies  ·  founded 2006  ·  US

Last verified

Zio ECG patch service: a deep-learning algorithm flags arrhythmias, cardiac technicians validate them, and a physician report follows.

Visit Zio (opens in new tab)Read our methodology

At a glance

Pricing
No public price.
HIPAA
Not disclosed
SOC 2
Not disclosed
EHRs
—
Founded
2006
HQ
US
On this page

Independent score  ·  By our public rubric

69/100Top-ranked

Editorial rating 4.5 / 5

How it’s computed →
  • Regulatory & Compliance
    12/22

    FDA cleared (18 K-numbers on record)

  • Clinical Integration
    0/11.6

    No EHR integrations listed

  • Evidence Strength
    30/30

    5 peer-reviewed papers

  • Vendor & Market
    14.4/18

    Mid-tier funding and adoption

  • Sentiment & Transparency
    1.3/2.5

    Pricing on request, no public amounts

▸ Show all 11 dimensions

Regulatory & Compliance

  • FDA clearance12/12

    FDA cleared (18 K-numbers on record)

  • HIPAA / SOC2 / BAA0/10

    No public HIPAA/SOC2/BAA attestation

Clinical Integration

  • EHR integrations (count)0/6

    No EHR integrations listed

  • Top-3 EHR coverage (Epic / Oracle / Athena)0/5

    None of the top-3 EHRs covered

  • Bidirectional write-back0/1

    No bidirectional write-back documented

Evidence Strength

  • Peer-reviewed papers21/21

    5 peer-reviewed papers

  • RCT / meta-analysis / systematic review9/9

    1 RCT/Meta-Analysis/Systematic Review

Vendor & Market

  • Funding & adoption signal8/12

    Mid-tier funding and adoption

  • Years in market6/6

    Founded 2006 (20 years)

Sentiment & Transparency

  • Pricing transparency1/3

    Pricing on request, no public amounts

Scored November 2, 2026 · Public scoring method v1.2.0

Zio ECG patch service: a deep-learning algorithm flags arrhythmias, cardiac technicians validate them, and a physician report follows.

No public price.

Evidence record

FDA decisions
Show 13 more
Peer-reviewed

5 studies on PubMed: 3 other, 1 observational, 1 RCT, published 2024 to 2025. Read the literature summary

Verification
  • Score computed November 2, 2026, method 1.2.0
  • Review written November 2, 2026
Cite this record

MedAI Verdict, Zio record, https://medaiverdict.com/tools/irhythm, version November 2, 2026

Change history
View every change to this record

Bottom line

Zio is iRhythm's wearable ECG patch service. Per the vendor, a cloud deep neural network flags arrhythmias, qualified cardiac technicians validate the preliminary findings and a physician report follows. The FDA lists 18 clearances for the Zio line and its ZEUS software since 2008, but the FDA issued a warning letter on May 25, 2023, and the FY2025 annual report says FDA issues remain open. It fits practices that order ambulatory monitoring as a service, and a buyer wanting stand-alone AI for its own ECG recordings is looking at a different product.

Who runs it, and what does it sell?

Since January 12, 2026 the parent and SEC registrant is iRhythm Holdings, Inc., successor to iRhythm Technologies, Inc., which was incorporated in September 2006. The 10-K cites "more than twelve million patient reports." The service combines the Zio monitor and Zio AT patches, the ZEUS analysis system (Zio ECG Utilization Software), the ZioSuite clinician portal and the MyZio patient app. Zio AT adds mobile cardiac telemetry through a gateway, and a next-generation telemetry 510(k) was submitted in the third quarter of 2025.

What is on the FDA record?

All 18 records are 510(k) clearances, running from K081471 in June 2008 (ECARD and CCARD) to K252859 on May 29, 2026 (ZEUS Platform). The four most recent are K240029 on October 21, 2024 and K240177 on October 30, 2024, both for the Zio AT device, K243650 on August 15, 2025 for the Zio monitor and K252859.

The warning letter of May 25, 2023 said a Zio AT change was made without clearance and that the device was marketed to a new high-risk population. A Form 483 followed inspections in July 2024 at Cypress and San Francisco. The FY2025 10-K states that FDA issues remain open and that another warning letter, a consent decree or a recall is possible.

What supports the algorithm?

The vendor calls it "the first FDA-cleared, deep-learned algorithm verified by QCTs," reports 99% physician agreement on end-of-wear reports and says it is available in the US, EU, Switzerland, UK and Japan. The core paper is Hannun and colleagues in Nature Medicine, 2019 (PMID 30617320), on cardiologist-level arrhythmia detection with a deep neural network, which the vendor cites as the basis of its algorithm. A 2019 systematic review in Current Medical Research and Opinion covers arrhythmia detection with the Zio patch (PMID 31045463). Studies with iRhythm-affiliated authors include a 2025 BMJ Open paper on ambulatory ECG and heart failure or stroke events (PMID 40983571), a 2024 American Heart Journal paper on monitoring strategies in Medicare (PMID 38072334) and a 2025 Heart Rhythm paper on hypertrophic cardiomyopathy (PMID 39307380). The wider Zio literature runs to 55 papers on PubMed, mostly cohort studies that use the patch as a tool.

Billing and comfort

iRhythm publishes no price and bills payers through Medicare-enrolled IDTFs, per the 10-K. A 2024 company press release reported skin irritation of 0.47% for the new Zio monitor against 1.35% for Zio XT, a vendor-sponsored figure.

The verdict

A cardiology group that outsources ambulatory ECG monitoring is Zio's customer, buying from a vendor with 18 FDA clearances behind its patches and software and an open 2023 warning letter. A hospital that wants an algorithm to run on its own ECG data is looking at a different product, since iRhythm's offer is the monitoring service.

Editorial review last generated November 2, 2026. Synthesized from clinician sentiment, peer-reviewed coverage, and our editorial silo picks. Refined by hand where vendor facts change.

What it costs

All tiers are custom-quoted. The vendor does not publish per-provider list pricing.

TierMonthlyAnnualNotes
EnterpriseNot statedNot statedNo public price.

Source: vendor pricing page. Last checked November 2, 2026.

What deploys cleanly

Carries FDA 510(k), CE per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.

Who builds it

Zio (iRhythm Technologies) was founded in 2006 in US, putting it 20 years into market.

What the literature says

5 peer-reviewed studies indexed on PubMed evaluate Zio in clinical contexts. The most relevant are shown below, ranked by editorial relevance score combining title match, study design, recency, and journal tier.

Physical activity cut-points for older adults using the Zio XT onboard accelerometer. (opens in new tab)
Etzkorn LH, Davoudi A, Dooley EE, et al.· BMC Digit Health· 2024
The ZioXT continuous ambulatory electrocardiographic monitor (Zio) contains an accelerometer that can help quantify an individual's physical activity in the free-living environment. (1) To estimate activity cut-points to estimate daily time spent performing very light, light, or moderate to vigorous physical activity (VLIPA, LIPA, MVPA) for the Zio accelerometer. (2) To describe how Zio's 24-h wear protocol affects estimates of daily MVPA relative to a waist-worn accelerometer's waking-wear protocol. Three hundred eighty one participants from the Atherosclerosis Risk in Communities (ARIC) stu…
Validation of a Zio XT Patch Accelerometer for the Objective Assessment of Physical Activity in the Atherosclerosis Risk in Communities (ARIC) Study. (opens in new tab)
Davoudi A, Urbanek JK, Etzkorn L, et al.· Sensors (Basel)· 2024
Combination devices to monitor heart rate/rhythms and physical activity are becoming increasingly popular in research and clinical settings. The Zio XT Patch (iRhythm Technologies, San Francisco, CA, USA) is US Food and Drug Administration (FDA)-approved for monitoring heart rhythms, but the validity of its accelerometer for assessing physical activity is unknown. To validate the accelerometer in the Zio XT Patch for measuring physical activity against the widely-used ActiGraph GT3X. The Zio XT and ActiGraph wGT3X-BT (Actigraph, Pensacola, FL, USA) were worn simultaneously in two separately-f…
Zio® XT Patches in Pediatrics During the COVID-19 Pandemic: Comparisons Between In-Person and Mail-Home Application. (opens in new tab)
Khan MS, Dawson AY, Snyder C· Pediatr Cardiol· 2025Observational
The Zio&#xae; (Zio) XT Patch is a 14-day continuous ambulatory ECG monitor. During the Covid-19 pandemic, Zios were mailed directly to patients for self-application. The purpose of this study was to compare the percent artifact, a marker for quality, of in-clinic (IC) to mail-home (MH) applications in a pediatric population. A single-center, IRB-approved study of patients 0-&#x2009;<&#x2009;21&#xa0;years of age with Zios was studied for wear and artifact time filtered out based on iRhythm's proprietary algorithm. In total, 284 Zios were randomly selected and analyzed for total wear time and a…
Active Monitoring for AtriaL FIbrillation (AMALFI): Rationale, protocol, and pilot for a pragmatic, randomized, controlled trial of remote screening for asymptomatic atrial fibrillation. (opens in new tab)
Wijesurendra R, Pessoa-Amorim G, Buck G, et al.· Am Heart J· 2025RCT
Screening for asymptomatic atrial fibrillation (AF) might reduce cardioembolic strokes and screening for asymptomatic AF is recommended by some international guidelines. However, any impact of AF screening on clinical outcomes depends on a sustained increase in AF detection and anticoagulation use over time than would have occurred with routine care alone, highlighting the importance of long-term studies to generate the evidence needed to justify establishing formal screening programs. AMALFI aims to establish the long-term efficacy and cost-effectiveness of remote screening for asymptomatic…
Utilisation of ambulatory ECG monitoring for prediction of heart failure and stroke events and healthcare expenditure in treated and untreated patients: a retrospective cohort study. (opens in new tab)
Schwennesen H, Li Z, Hammill BG, et al.· BMJ Open· 2025
We evaluated the performance of risk models that incorporate ambulatory ECG data and clinical information for prediction of healthcare expenditures related to heart failure (HF) and stroke events in treated and untreated patients. A retrospective cohort study of Medicare patients who underwent Zio XT ambulatory monitoring in the USA was conducted between 2014 and 2020. 14-day ambulatory ECG data and claims data were evaluated in the study sample which included 89&#x2009;923 patients in the HF hospitalisation group, 75&#x2009;870 in the new-onset HF group and 90&#x2009;159 in the stroke hospit…

See all on PubMed (opens in new tab)

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