ZBeats announcement · September 2026
FDA 510(k) clearance
for ZBPro Diagnostic v2.0
Expanded to support wearable ECG patches and recordings from 1 minute to 14 days.
Independent ECG intelligence built to integrate. Automated retrospective analysis, professional review, and reporting for supported Holter and patch recordings.
FDA clearance K261580 · For qualified healthcare professionals
ZBPro Diagnostic v2.0 · Professional ECG review
Clinical validation
Expand your recording options.
Keep confidence in the analysis.
Your choice of recorder should support your service—not dictate a separate standard of analysis. ZBPro brings supported Holter and patch recordings into one clinically validated environment.
71M+
heartbeats
430K+
arrhythmia episodes
5,500
patients
14
rhythm classes
13
recording device configurations
Different devices.
A consistent foundation.
The question was direct: does performance hold when the recording technology changes?
The evidence supports it. Testing demonstrated performance equivalence across the evaluated Holter and patch configurations and source devices. Adding the wearable patch configuration preserved the established Holter performance basis.
Results were examined by recording configuration and device, as well as across the expanded population. Differences were investigated in clinical and statistical context; no unresolved finding demonstrated a clinically meaningful device- or configuration-specific limitation.
For your organization, that supports a common analysis and review workflow as you adopt supported recording technologies. Equivalence applies to evaluated devices and configurations under tested conditions.
Supported inputs span three Holter configurations and the added single-lead wearable ECG patch configuration. Automated analysis uses one designated diagnostic lead.
Built around your operation
Your operational challenges.
Our focus.
01
Diagnostic providers & IDTFs
Different recorders. One way to run your studies.
Your technicians need a consistent workspace across the devices you support. ZBPro brings qualified Holter and patch recordings into the same analysis, editing, and reporting environment—with study assignments, shared findings templates, and supervisor review before release.
02
Device manufacturers
Keep your focus on the device. Connect to a cleared analytical core.
Give your supported ECG hardware a pathway to automated analysis and technician review without building every software capability in-house. ZBPro offers an FDA-cleared analytical core, API connectivity, and integration expertise for your device and service model. Each integration remains subject to input qualification and its applicable regulatory scope.
03
CROs & research teams
Distributed recordings. A consistent review environment.
Across sites, participants, and study visits, your team needs findings it can examine and compare in context. ZBPro brings supported ECG recordings, rhythm burden, diary events, and the underlying strips into one review environment. Configurable findings templates help align reports with your study workflow.
ECG insight for RPM programs
Bring supported recorded ECG into your remote-care workflow with retrospective analysis and technician-reviewed reports. ZBPro Diagnostic supports assessment after recording; it does not provide live surveillance or real-time alerts.
Technician Review and Reporting
Give your technicians
the full picture.
From a multi-day rhythm pattern to an individual beat, ZBPro connects the views, editing tools, and reporting controls your team needs to turn automated findings into a reviewed study.
Advanced tools.
Technician control.
Connected views reveal the context. Heart Rate Density and Lorenz plots link patterns to the corresponding ECG and episode cards. Time-range and beat selections focus the review on the evidence behind a finding.
Powerful editing at the scale you need. Individual beat corrections, batch selection, and morphology split, merge, and reclassification tools put detailed control in your technicians’ hands. Dense and detailed ECG views keep surrounding rhythm in sight.
Reports built from the reviewed study. Configurable findings templates populate available study metrics, while selected ECG strips document the findings. A defined supervisor overread and return-for-revision workflow supports final release.
NoiseGuard™: quality comes first
Your team needs to know when a recording cannot support automated analysis. NoiseGuard™ flags studies that fail signal-quality criteria and preserves a manual-review pathway. Affected reports are watermarked to make the absence of automated analysis explicit.
Within the analysis, segments identified as artifact are excluded from beat classification, interval measurements, and arrhythmia detection. Signal limitations stay visible to the professionals interpreting the study.
The episode is only the beginning
Onset, fastest segment, and offset views put longer episodes in context. Patient diary entries connect symptoms and activities to the ECG. Rhythm burden, heart-rate trends, HRV, and beat morphology give your team more ways to examine what happened—and support the findings they report.
Integration & organizational fit
Your ECG sources.
Your service model.
A shared analysis layer.
Put ZBPro to work in a standalone technician workspace or connect its analysis through your existing software. We work with your team to align the recording pathway, review responsibilities, and outputs with the service you deliver.
01 / INPUTS
A pathway for your supported devices
EDF, ISHNE, and MIT-BIH / WFDB inputs connect qualified Holter and patch recordings to a common analytical core. Defined signal and file requirements establish what your integration must deliver.
02 / WORKFLOW
Your team’s expertise, built into the process
Role-based workspaces connect study intake, technician analysis, and clinical supervision. Assignments, review status, and report return controls make responsibilities visible across the study lifecycle.
03 / OUTPUTS
Analysis that connects to your service
API integration gives your software a pathway to study data, analysis results, and report outputs. Pair that connectivity with configurable reporting to fit how your organization delivers ECG services.
Looking ahead
ZBPro MCT
A separate future offering in the ZBeats product family.
Planned availability · Q2 2027
Not commercially available until Q2 2027.
ZBPro MCT is separate from ZBPro Diagnostic v2.0. The FDA clearance announced above applies to Diagnostic v2.0 and does not establish clearance for MCT.
About ZBeats
Independent intelligence.
Connected to clinical work.
Founded in 2019 and headquartered in Stony Brook, New York, ZBeats Inc. develops cloud-native ECG intelligence. Our focus is the analysis, professional review, and integration layer that helps organizations turn supported ECG recordings into structured clinical information.
Let’s talk
Bring us your
ECG challenge.
Adding a recorder? Expanding your diagnostic service? Connecting ECG analysis to a study or platform? Tell us what you need to accomplish. We’ll focus the conversation on your workflow.
Request a demonstration, discuss an integration, or arrange a conversation at HRX Live 2026.
Start a conversation
For qualified healthcare professionals. ZBPro Diagnostic v2.0 supports retrospective analysis of compatible ambulatory ECG in adults. It is not intended for pediatric patients, paced signals, real-time monitoring, alarm functions, or emergency use. Results support professional interpretation and are not the sole basis for diagnosis. Use only supported inputs within the cleared indications and applicable instructions for use.