Frequently asked questions.
Answers to the most common questions clinicians, engineers and procurement teams ask before adopting Cardiolyse.
Everything you need to know
Answers to the most common questions clinicians, engineers and procurement teams ask before adopting Cardiolyse.
What Cardiolyse actually is, and which product does what.
Cardiolyse is a cloud ECG and HRV analytics platform. You send a digital ECG recording, and it returns structured findings — rhythm, intervals, morphology and heart-rate variability metrics — for review by a qualified healthcare professional. It is device-agnostic and API-first, so it sits behind whatever hardware or product you already use.
No. Resting ECG and Holter ECG run on separate platforms. They share the same analytics foundation, but the recording lengths, workflows and reporting differ enough that we keep them apart rather than pretending one interface fits both. Tell us which one you need and we will point you at the right platform.
It is the review interface: a worklist where a clinician can open a recording, inspect the AI findings, edit them, and sign a report. It is available to support the cardiologist’s work alongside the automated analysis, rather than replacing the sign-off step.
Up to around 300 ECG and HRV parameters, depending on the recording type and lead count. That includes the standard interval and morphology measurements plus heart-rate variability metrics used for cardiovascular risk and recovery analytics.
Yes, but we separate them deliberately. HRV and wellness analytics are not a diagnostic claim and sit outside the certified intended purpose. The certified diagnostic output and the wellness analytics are presented distinctly so nobody confuses the two.
How the models were built, how they are validated, and what we will not claim.
Our AI is trained and validated against expert-annotated ECG data sets. The platform is CE-marked as Class IIa medical device software and is designed to augment — not replace — clinician judgement. MDR regulation requires a strict view of our validation and model training.
Cardiologist sign-off remains part of the workflow for regulated diagnostic use.
Rest assured, Cardiolyse can deliver best-in-class output and accuracy data. More details available under NDA.
Our published studies and validation summaries are collected on the clinical evidence page, with the full clinical evaluation available to partners under NDA.
Yes, and we prefer it. Send a small anonymised batch that reflects your real case mix, and we will run it through the platform and walk you through the output. It is a more honest test than any accuracy figure in a slide deck.
Performance depends on what the leads can physically show. Reduced-lead and single-lead recordings support rhythm and interval analysis well, while findings that require spatial information across the chest need the full 12-lead set. We will tell you which findings are supportable on your lead configuration rather than returning everything regardless.
What you can send us, and how the results get back into your systems.
Any digital ECG from 1 to 12 leads. That includes standard 12-lead diagnostic ECG carts, ambulatory Holter monitors, single- and multi-lead patches, and 6-lead consumer wearables.
Common formats including EDF, XML, DICOM-ECG and PDF, plus proprietary vendor exports. If you have a format we have not seen, send a sample and we will tell you whether we can read it.
Through a documented REST API that returns structured results you can map into your own interface, PACS or cardiac module. See the ECG API page for the integration model.
Yes. The API returns structured results that map cleanly to PACS or a dedicated cardiac module, and our team can work directly with your integration partner.
Yes. ECG digitisation converts printed or scanned traces into analysable digital signals, which is often the route into historical archives. See ECG digitisation.
Yes. The review dashboard can be white-labelled or co-branded (based on regulatory requirements) so it appears as part of your product rather than ours.
The certified scope, stated plainly.
Yes. Cardiolyse is CE-marked as Class IIa medical device software under EU Regulations and operates under an ISO 13485 quality management system. Full detail is on the certifications and compliance page.
The automated analysis of digital ECG recordings and the presentation of findings to a qualified healthcare professional, as support for clinical judgement. HRV and wellness analytics, research work and investigational features sit outside that certified purpose and are handled separately.
The CE certification covers the European Economic Area, and we hold NHS Digital DSP Toolkit certification for handling patient data in the UK. Deployments elsewhere depend on local requirements, and we will be explicit about what is and is not approved in your jurisdiction before a pilot starts.
Yes. The intended purpose is to support a qualified healthcare professional. Findings are presented for review and clinician sign-off remains part of the diagnostic workflow.
Where patient data lives and who can reach it.
All data is transmitted over TLS, stored encrypted at rest, hosted in EU data centres, and processed under a signed Data Processing Agreement. Controls are ISO 27001-aligned and GDPR-compliant, and Cardiolyse is certified by NHS Digital for Data Security and Protection compliance.
We process health data under a signed DPA with defined purposes, retention and deletion. Data stays in EU infrastructure, access is role-based, and every action against a recording is captured in an audit trail. Pseudonymised workflows are supported where a study design calls for them.
Yes. Alongside the hosted EU deployment, the analytics engine can be deployed into your own cloud tenancy or an isolated environment where data residency or network policy requires it. These are scoped with your IT and compliance teams.
How engagements are structured and what the first step looks like.
Licensing is usually per-analysis or per-seat for clinical deployments, and volume-based for API and OEM integrations. Research and study work is scoped per project. We will put the structure in writing before anything starts.
Most provider deployments go live on the web dashboard within two to four weeks. Deeper integrations and on-premises options are scoped case by case with your IT and compliance teams.
A small anonymised ECG batch, a conversation about the setting and the workflow around it, and a walkthrough of the output. The point is to establish whether the findings are useful in your case mix before anyone signs anything.
Yes. We take part in research programmes and funded consortia — see EU projects and case studies for programmes we have contributed to.
Write to info@cardiolyse.com or fill in our contact form for commercial and partnership questions, or support@cardiolyse.com if you are already using the platform.
Ask it directly. If it is a good question we will add it to this page, because it probably is not just you wondering.
