For medical device OEMs
Add clinical-grade ECG AI to any device — through one API.
Cardiolyse is a device-neutral, CE-marked ECG AI engine. Call it through our EU-hosted cloud API, or run the same certified engine as a container inside your customer's cloud or data centre — and turn any 1- to 12-lead recording from your monitor, wearable, patch or Holter into structured, clinician-ready findings.
For hardware and software OEMs
Ship a smarter device without building your own algorithm.
Certified ECG AI is expensive to build, harder to certify and even harder to maintain at clinical quality. Cardiolyse ships you the interpretation layer — you keep your device, your customer relationship and your brand.
One REST API, any device
Send an ECG in, get structured findings back. Same contract for a wearable patch, a 12-lead resting ECG cart or a Holter recorder — 1 to 12 leads, seconds to days of signal. Full API documentation.
EU cloud or customer-hosted
Call the API from our EU cloud, or run the same certified engine as a container inside your customer's private cloud, VPC or data centre when latency, sovereignty or data-residency requirements demand it. The analysis engine runs as a service — it is not embedded on the device itself.
CE-marked medical device software
Cardiolyse is CE-marked as Class IIa under EU Regulations and operates under an ISO 13485 QMS. Your regulatory affairs team gets a documented, auditable AI component to plug into your device's technical file.
Two hosting options
Cloud API or a container in your customer's cloud — same engine, same certification.
Two hosting options for the same certified analysis engine. Pick the one that fits your customer's data-handling policy and connectivity model — the clinical output is identical, and Cardiolyse always runs as a service, never as embedded software on the device.
Direct cloud API
Point your product at Cardiolyse's EU-hosted REST API and start returning interpretations in days. No infrastructure to run, no models to retrain, no regulatory rework — you consume a certified service.
- REST + JSON, signed with API keys
- EU-hosted, ISO 27001-aligned data pipeline
- Ingests EDF, XML, DICOM-ECG, PDF and proprietary vendor exports
- Structured, standards-compliant JSON output + PDF report
- Elastic scale for screening and telemedicine volumes
Customer-hosted container
Deploy the same certified analysis engine as a container inside your customer's cloud, VPC or hospital data centre. Ideal for IT teams that require ECGs never leave their network, and for national deployments with sovereignty rules. The engine still runs as a service — it is not embedded in the device.
- Container-based deployment (Docker / Kubernetes)
- Runs air-gapped or in a private VPC
- Same REST API contract as the cloud service
- Signed image releases with QMS-controlled versioning
- Optional customer-hosted dashboard for clinician review
How the integration works
Four steps from your device to a clinician-ready result.
The same integration pattern applies whether you ship a patch, a Holter, a consumer wearable or a 12-lead diagnostic ECG cart.
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01
Capture
Your device records ECG signal — 1 to 12 leads, at your native sampling rate — and packages it in any common format.
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02
Send
Post the recording to the Cardiolyse REST API — our EU cloud, or the container running in your customer's cloud. Authentication is per-tenant, per-device or per-clinician.
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03
Analyse
The certified engine returns up to 300 vital ECG parameters, HRV metrics, arrhythmia labels and a Personal Baseline Score.
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04
Deliver
Consume the structured JSON in your app, or render the Cardiolyse PDF report inside your product — under your brand.
Optional companion
Ship the web dashboard with your device — under your brand or ours.
Not every device team wants to build a full clinician UI. Bundle the Cardiolyse web dashboard so your customers get a ready-made review, sign-off and reporting surface out of the box — with white-label options for your brand.
Clinician-ready UI, day one. Skip the design and clinical-UX cycles — offer a proven review, annotation and sign-off workflow that hospital users understand immediately.
White-label ready. Custom logo, colours and domain, so the dashboard sits inside your product story without breaking your brand.
Role-based access & audit trail. Suitable for regulated environments — clinician, admin, technician and read-only roles, with full event logging.
Faster time-to-market. Focus your engineering on the device — we maintain the interpretation UI and its regulatory documentation.
Working with device makers & research partners
Trusted by manufacturers, clinical centres and researchers across Europe.
Frequently asked
Questions integration and regulatory teams ask us first.
How do we integrate the Cardiolyse ECG AI into our device?
Two ways, both service-based — the engine is not deployed on the device itself. (1) Call our EU-hosted REST API directly from your device or backend — full documentation at api.cardiolyse.com/docs. (2) Deploy the same certified engine as a container inside your customer's cloud, VPC or data centre. The API contract is identical in both modes.
Which ECG formats and lead counts does the API support?
The API ingests 1 to 12 leads at your device's native sampling rate. We support EDF, XML, DICOM-ECG, PDF and common proprietary vendor formats. Output is structured JSON — waveform-parameter measurements, arrhythmia labels, HRV metrics and risk scores — with a signed PDF report. Additional standards-based output formats are available for teams that need them; our integrations team maps the schema to your downstream system.
Can Cardiolyse run in our customer's own cloud or air-gapped environment?
Yes. We ship the same certified analysis engine as a container image, deployable on Docker or Kubernetes inside your customer's cloud, VPC or data centre. Air-gapped installations are supported for hospitals and public-sector customers with strict data-residency requirements. The engine runs as a service in that environment — it is not deployed on the device itself.
Is Cardiolyse certified as a medical device?
Yes. Cardiolyse is CE-marked as Class IIa medical device software under EU Regulations. We operate under an ISO 13485 quality management system, so your regulatory affairs team receives a documented, auditable AI component — including declarations of conformity — to include in your device's technical documentation.
How does the AI perform on non-standard lead configurations?
The algorithm is validated across 1- to 12-lead configurations on data from wearables, patches, Holter monitors, and diagnostic ECG carts. Performance benchmarks by device class are available under NDA on request.
Can we white-label the web dashboard?
Yes. White-labeling and co-branding are possible. The Cardiolyse web dashboard can be delivered under your brand — custom logo, colour palette and domain — so your clinician-facing users see one coherent product experience.
What's the licensing model?
We license per active user, per analysed recording, or under enterprise volume agreements — depending on your product economics. Talk to us and we'll size a model that fits your device pricing.
For everything else, see the full FAQ.
Ready to add clinical-grade ECG AI to your device?
Send us a sample recording, or start with the API docs. Our integrations team will scope your fastest path to a working prototype.