Decision-supporting Workflow
A smoothly running web dashboard allows doctors to work more effectively, supporting easy report approvals and adjustments.
AI-powered ECG Analytics for Screening and Precision Medicine.
Advanced heart analytics that automate ECG interpretation, identify high-risk patients, and support precision cardiology workflows.
Analyzing ECG · sinus rhythm detected · 68 bpm
- 30+ arrhythmias detected
- CE Class IIa certified
- API / SDK available
- Resting ECG analytics
- ECG Digitalization
- Device-agnostic integration
0+
Arrhythmias detected across resting & Holter ECG
CE IIa
Certified medical device software under EU Regulations
Days
Typical time to first production integration — not months
Any device
Works with any ECG source — clinical, Holter, or wearable
Trusted by our commercial and project partners
How it works
From raw signal to clinical decision — in under 30 seconds.
Any ECG source, any format. Our pipeline handles ingestion, preprocessing, AI interpretation, and clinician-ready reporting through one secure API.
01
Ingest
Upload ECGs from Heart monitors, 12-lead devices, consumer wearables, or your existing EHR. Supports all the most used data formats.
02
Analyze
Cardiolyse AI detects 30+ arrhythmias and heart abnormalities, computes HRV, and generates individual cardiovascular risk scores.
03
Report
Clinicians receive a structured, annotated report in seconds with the ability to adjust the findings. Exportable to PDF, HL7 FHIR, or embedded directly into your telecardiology workflow via API.
Platform capabilities
Built for cardiology teams. Not for demos.
Over a decade of clinical R&D, more than 1 million ECGs analysed, and direct feedback from cardiologists across Europe.
20+ arrhythmia classes
AFib, AFlutter, PVCs, PACs, SVT, VT, bradycardia, bundle branch blocks, and more — trained on multi-center, expert-labeled datasets.
Multi-device ingestion
Home-use single-lead ECGs or wearables, 12-lead hospital devices — one pipeline, adjustable report format.
REST API integration
Drop-in integration with EHRs, telecardiology platforms, and consumer health apps. Standards-first SDKs.
Structured reporting
PDF, HL7, JSON, DICOM-SR. Clinician-signed, auditable, exportable to any downstream system in your stack.
Who Cardiolyse serves
Different audiences. One clinical-grade solution.
Whether you are a cardiologist reading ECGs, a hospital scaling remote monitoring, or a device maker embedding AI, Cardiolyse fits your workflow, not the other way around.
For Clinicians
Read ECGs in seconds
Automatic pre-classification of every beat, waveform annotations, and an editable report you sign — not one you rebuild from scratch.
- Any lead count and any duration
- Auto-generated draft reports
- Full editable annotations
For Health Systems
Scale cardiac care beyond your walls
Deploy Cardiolyse across ambulatory, remote-monitoring, and telehealth workflows with one enterprise contract and one API.
- Enterprise SSO & audit logs
- Regional data residency (EU)
- Volume-based pricing
For Device Makers
Add more value to your users
A regulatory-ready ECG analysis backend behind your device or app — CE-marked algorithms, white-label reporting, and OEM licensing.
- White-label REST/SDK integration
- Co-badged CE technical file support
- OEM licensing models
Clinical validation
Evidence, not marketing.
Cardiolyse is built on more than a decade of clinical R&D and validated in collaboration with cardiologists and research centres across Europe.
0+
Years of clinical R&D in ECG and HRV analysis
0M+
ECGs analysed by the Cardiolyse platform to date
0
Vital ECG parameters extracted per recording
CE
Class IIa medical device software under EU Regulations
Regulatory & trust
Built to medical-device standards. Audited. Certified.
Cardiolyse is not a research prototype. It is a documented, audited medical device operating under EU Regulations, ISO 13485 quality management, and ISO 27001-aligned information security, certified by NHS Digital for Data Security and Protection compliance.
CE
CE-marked · Class IIa
Cardiolyse is CE-marked as Class IIa medical device software under EU Regulations. Technical file and clinical evaluation available under NDA.
ISO
ISO 13485 · GDPR
Certified quality management system for medical devices and full GDPR compliance for the processing of health data across the EU.
NHS
NHS Digital DSP Toolkit
Certified by NHS Digital for Data Security and Protection compliance, meeting the standards required to handle patient data within the UK National Health Service.
Clinicians on Cardiolyse
Trusted across preventive cardiology, medical devices and clinics.
Real users. Real workflows. Real clinical impact.
In preventive cardiology, we cannot wait for a cardiac event to act. Cardiolyse gives us the ECG analytics we need to detect subtle risk signals early, at scale, and to build genuinely personalised prevention protocols.
Dr. Massimo Gualerzi
Cardiologist · The Longevity Suite Clinics
Embedding Cardiolyse's single-lead ECG algorithms into the MedicubeX eHealth Station gave us clinically credible cardiac analytics out of the box — the kind of interpretation our medical users trust when a patient does a self-check.
Vili Kostamo, MD
Medical Doctor · CEO, MedicubeX
Cardiolyse offers customers a clean REST API on the integration side, and a web dashboard that cardiologists enjoy using and that supports their remote ECG workflow.
Pekka Pirttiaho
VP Business Development · Cardiology Centre
Technical specifications
Everything your CIO will ask about.
Cardiolyse is engineered for hospital-grade deployment — secure, interoperable, and built to fit your existing stack rather than replace it.
Supported inputs
Any ECG source
- 1-, 3-, 6-, and 12-lead ECG
- Any duration ECGs
- EDF, XML, PDF, DICOM-ECG, PNG
- Consumer wearables (Apple, Withings, KardiaMobile)
AI capabilities
300+ Biomarkers
- Rhythm classification (30+ arrhythmias)
- ST-segment abnormality detection
- Heart-rate variability & time-domain metrics
- Cardiolyse Wellness Risk Scores
Integration
API-first
- Easy REST API integration
- Fully documented process
- Tech support for integration
- Customization and specific integration options
Deployment
Cloud or on-premises
- EU-hosted managed SaaS (default)
- Private VPC deployment
- On-premises container option
- 99%+ SLA · uptime status page
Security
ISO 27001 · NHS DSP
- ISO 27001-aligned information-security controls
- NHS Digital Data Security & Protection compliance
- SSO, MFA, role-based access control
- Full audit trail, tamper-evident logs
Compliance
CE · GDPR
- CE-marked medical device software · Class IIa
- ISO 13485:2016 quality system
- GDPR-compliant data processing (EU DPA)
- HIPAA-aligned architecture
Latest from Cardiolyse
Updates from the Cardiolyse team on product, clinical research, partnerships and events.
Device integration · 28 August 2025
Cardiolyse and MedicubeX deepen their collaboration
Cardiolyse ECG analytics runs inside MedicubeX autonomous eHealth Stations, turning a routine self-service check into heart-health risk profiling. Live in Finland, Germany, the UK, Latvia and Estonia.
Read the article
Clinical pilot · April 2022
Post-ablation telemonitoring with GVM Care & Research at Maria Cecilia Hospital
Forty patients followed for twelve weeks at home after atrial ablation, with the arrhythmology and electrophysiology unit in Cotignola, Italy. Clinicians and patients gave positive feedback, and their input shaped our roadmap.
Read the article
Hospital pilot · June 2023
Cardiolyse improves cardiovascular care at Oxford University Hospitals
Taken through TheHill Oxford’s formal pipeline process to pilot stage at the John Radcliffe Hospital, working with one of the leading cardiologists at Oxford University Hospitals.
Read the article
European procurement · 2021–2026
CRANE: pre-commercial procurement for remote chronic care
A European pre-commercial procurement for chronic care in rural areas. Cardiolyse brought heart-health screening analytics for home ECG recordings on a Beurer device, across three countries.
Read the articleFrequently asked questions
Answers before your next question.
The six questions we hear most from clinicians, device manufacturers and pharma teams evaluating Cardiolyse. For everything else, see the full FAQ.
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Yes. Cardiolyse is a CE-certified medical device software under EU Regulations. Our ECG & HRV analytics module is intended for use by qualified healthcare professionals as decision support alongside clinical judgement — not as an autonomous diagnostic system.
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Cardiolyse is device-agnostic. We ingest signals from resting 12-lead ECGs, Holter monitors, patch recorders, and medical-grade wearables. Supported inputs include standard EDF, DICOM-ECG, HL7 aECG, XML exports, and other raw sample streams. Paper and PDF ECGs can be digitized through our ECG digitization pipeline.
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We provide secure REST API access. Typical integration: your EMR or device sends the ECG payload; Cardiolyse returns structured measurements, interpretations, and risk scores in JSON, plus an optional PDF report and FHIR-compatible resources for downstream systems.
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All patient data is processed and stored in EU data centres, in line with GDPR and the EU regulatory post-market surveillance requirements. Cardiolyse operates a documented information-security programme aligned with ISO 27001 principles and is certified by NHS Digital for Data Security and Protection compliance, with encryption in transit and at rest, role-based access, audit logging and data-processing agreements (DPAs) available for every customer.
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Yes. We support Phase I–IV cardiac safety and endpoint programmes with centralised ECG reading, automated measurement, arrhythmia adjudication support, QT/QTc analysis and blinded review workflows. Studies benefit from consistent, reproducible measurements across sites, protocol-configured escalation rules and audit-ready exports. See Clinical Trials & Pharma for the full scope.
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Most customers begin with a scoped proof of concept: 2–4 weeks, a defined ECG dataset or device stream, and clear criteria agreed up front. A successful PoC moves into a paid pilot (typically 8–12 weeks) with API integration and clinical validation, then into a commercial rollout. Pharma sponsors start directly at a study-specific Statement of Work. We can usually align on a plan within a week of the first call.
See how Cardiolyse can support your specific workflow.
Book a 25-minute exploration call or send us an email.
- Bring your use case
- Live demo
- Integration & pricing plan the same week