SmartCardia
SmartCardia pairs a cable-free 7-lead ECG patch worn for up to 14 days with a cloud platform whose machine learning flags arrhythmias automatically, covering Holter, extended Holter, event monitoring and mobile cardiac telemetry from one single device.
What is SmartCardia?
SmartCardia is an end-to-end cardiac monitoring solution built from two halves: a cable-free 7-lead ECG patch and a cloud SaaS platform that analyses what the patch records. It is published by SmartCardia SA, a Swiss medical technology company based at the EPFL Innovation Park in Lausanne and entered in the Vaud commercial register on 29 October 2013.
The patch records seven ECG leads rather than the one to three typical of competing wearables, which the company credits for clean P-wave and QRS morphology and very low signal noise. It also captures respiration, SpO2 and activity. It is worn without cables, is shower and water resistant, and a single patch can stay in place for up to 14 days. The electronic sensor is reusable from one patient to the next and never needs charging, while the disposable element is deliberately low cost.
Analysis is handled by SmartNeuralNet, a machine learning engine developed from millions of ECG segments annotated by cardiologists and certified cardiac technicians. All seven leads stream to the cloud in near real time, and the platform analyses the complete signal, described as full disclosure, rather than only the segments surrounding a detected event. Arrhythmias and signs of patient deterioration are flagged automatically and pushed to clinicians, who work from a dashboard offering one-click arrhythmia display and navigation before and after any event.
One notable design choice is that a single patch serves four distinct service types: mobile cardiac telemetry and remote patient monitoring, Holter, extended Holter and event monitoring. A clinician can move a patient from one mode to another remotely, with no return visit.
The regulatory record is substantial. SmartCardia obtained FDA clearance for outpatient cardiac telemetry on 13 November 2024, after earlier clearances for Holter, extended Holter and event monitoring, and holds CE Class IIa approval in Europe. The company is certified to ISO 13485 and ISO 27001, both certificates being published. It reports more than 100 hospitals, over ten clinical studies and a 2022 Frost & Sullivan Global New Product Innovation Award. In the United States it now delivers the whole pathway itself, through an accredited diagnostic testing facility acquired in December 2024.
What it does
- Records seven ECG leads continuously for up to 14 days
- Detects cardiac arrhythmias and patient deterioration automatically, then notifies clinicians
- Streams 100% of the trace to the cloud in near real time, not only the flagged events
- Measures respiration, SpO2 and activity alongside the ECG
- Switches remotely between Holter, extended Holter and mobile cardiac telemetry without a patient visit
- Generates beat-level accurate reports from the full-disclosure recording
- Presents the whole recording on a clinician dashboard with one-click arrhythmia display
When to use SmartCardia / When not to
A quick filter to help you decide if SmartCardia is the right fit.
When to use SmartCardia
- Cardiologists and electrophysiologists who need high arrhythmia detection accuracy from seven ECG leads
- Hospitals wanting one device to cover screening, post-discharge follow-up and long-term remote monitoring
- Cardiology departments looking to cut analysis time and staff cost with a reusable sensor and a low-cost disposable patch
- Care teams that need near-real-time alerting rather than a report delivered once the recording has ended
- Clinical research teams collecting continuous ECG and vital-sign data across study cohorts
When not to use SmartCardia
- Patients hoping to buy a monitor directly, since the service is available by physician prescription only
- Anyone looking for an emergency response system, which the terms explicitly state this is not
- People under 18, who are excluded by the terms of use of the US service
- Teams that need an API or an EHR integration, as none is published or documented anywhere
- Buyers who require a published price before engaging, because no pricing is disclosed at all
How to use SmartCardia
A typical end-to-end flow, from setup to results.
- Obtain a prescription, as the service is available only when ordered by a physician
- Receive the monitoring kit containing the 7-lead patch and its return packaging
- Apply the patch, which needs no cables and no charging and can be worn in the shower
- Install the patient app, pair it with the patch and accept the terms of use in the app
- Provide a mobile number to receive operational SMS alerts about the device
- Wear the patch continuously for the prescribed period, up to 14 days
- Let the patch stream all seven leads and the vital signs to the cloud over cellular coverage
- Clinicians review the full-disclosure recording on the cloud dashboard and act on automatic alerts
- Switch the patient remotely to another monitoring mode if the clinical picture changes
- Return the equipment as soon as the prescribed wear time ends, to avoid being billed for it
Pros & Cons
Pros
- Seven ECG leads where many competing patches offer only one to three
- Full-disclosure analysis of the entire recording rather than event extracts alone
- Explicit FDA clearance for outpatient cardiac telemetry, plus CE Class IIa approval in Europe
- ISO 13485 and ISO 27001 certified, with both certificates published as downloadable PDFs
- One device covers four service modes, with remote switching and no patient revisit
- Reusable sensor and low-cost disposable patch underpin the stated cost argument
- Integrated US pathway through an accredited IDTF with in-network insurance coverage
Cons
- No public pricing whatsoever: no pricing page, no rate card, no published range
- No API and no technical documentation, and no named EHR or third-party integration
- No subprocessor list is published and no data processing agreement is offered
- No data hosting country or region is disclosed anywhere on the site
- Prescription-gated, so there is no trial, no free plan and no way to evaluate it independently
- Contractual liability for the US service is capped at 100 USD, with mandatory arbitration
- A thin eleven-page site with no detailed product page and no demo
Pricing & Plans
SmartCardia publishes no pricing. There is no pricing page, no rate card and no indicative range, and there is neither a permanent free plan nor a free trial: this is a prescribed medical service rather than a self-service subscription, so commercial terms are handled by a dedicated sales organisation. In the United States the service is billed to the patient's insurer directly, and SmartCardia states in-network coverage with major insurers across the different monitoring modalities. The patient is then responsible for whatever the insurance does not cover, including deductibles and out-of-pocket costs. Equipment that is not returned promptly may be billed, and unpaid balances may be referred to a collection agency.
Data, GDPR & hosting
A consolidated view of how SmartCardia handles your data.
GDPR overview
GDPR is addressed explicitly rather than merely implied. The website privacy policy names Regulation (EU) 2016/679, states that SmartCardia maintains the corresponding register of processing activities, and says it has adopted technical and organisational measures suited to the data and to the state of the art. The full set of rights is offered: access, rectification, erasure, objection, restriction and portability. They are exercised by signed written request with proof of identity, sent to SmartCardia SA at the EPFL Innovation Park in Lausanne or by email to contact@smartcardia.com. Consent is collected via a tick box on the contact form, and cookies are limited to those essential to the site. Two gaps deserve mention: no Article 27 EU representative is designated, although the publisher sits in Switzerland and therefore outside the Union, and no data protection officer is named.
Who owns the data?
The website privacy policy states that data supplied through the contact form is held in a file owned by SmartCardia SA. For the US monitoring service, the clinical information generated by the prescribed device is protected health information governed by SmartCardia Inc.'s HIPAA obligations, and monitoring data is shared with the prescribing physician and their staff. Patients remain responsible for whatever they transmit, defined in the terms as Communications Data. SmartCardia owns the service itself and all of its Materials, and any feedback a user volunteers is granted to the company on an unrestricted, perpetual, irrevocable and royalty-free basis.
Reuse rights
End users receive only a limited, personal, non-transferable and revocable licence to use the service to monitor their own ECG data as prescribed. They may not reproduce, distribute, publicly display, reverse engineer or create derivative works from any part of it, nor sell, sublicense or transfer their access. Reuse of the data therefore requires permission rather than being granted by default. On the website side, SmartCardia states that contact-form data serves only to answer the request and is then deleted, that no advertising is sent, and that the data is neither passed to third parties nor transferred internationally. For the US service, personal information is not sold; sharing is confined to service providers and business associates bound by confidentiality or HIPAA agreements, or to cases where the law requires it. Mobile numbers and SMS consent data are excluded from any third-party marketing.
Data retention & training
Hosting summary
SmartCardia does not document where data is hosted. Neither the website privacy policy, nor the terms, nor the US service documents name a hosting country, a region or a provider, and the site has no trust or security page. Clinical data is described only as going to a secure cloud, with no location attached. The one adjacent statement comes from the website privacy policy, which says no international data transfers are made, but that sentence concerns data collected through the site's contact form rather than patient monitoring data, and it sits awkwardly next to the US privacy policy, which does describe sharing with service providers and business associates. For the US service the company commits to reasonable administrative, technical and physical safeguards, without detail. One factual note that must not be mistaken for a disclosure: the public website itself resolves to an IP address geolocated in Frankfurt, Germany, on Amazon infrastructure. That describes the marketing site's web server, not the jurisdiction of patient records, about which SmartCardia makes no claim.
Where SmartCardia works
Country-level availability.
Not available in
Things to keep in mind
Risks and trade-offs to weigh before adopting SmartCardia.
- This is an aid to diagnosis and not a diagnosis: the terms state the service gives no medical advice, interpretation or clinical suggestion, and treating an automatic alert as a verdict is the central misuse risk
- It is explicitly not an emergency response system, so a patient who feels safer because they are being monitored may delay calling for help
- Transmission depends on cellular coverage and can be interrupted, which means the absence of an alert is not evidence of the absence of an event
- The US terms impose binding arbitration, waive jury trial and class actions, cap total liability at 100 USD and set a one-year contractual deadline for any claim
- The published address is inconsistent: the footer and the terms say Building D at the EPFL Innovation Park, while section 2.4 of the privacy policy says Building C
- The footer copyright reads SmartCardia Inc. although the site and its terms are published by the Swiss parent SmartCardia SA, and the two legal corpora differ in governing law
- Adoption figures such as 100+ hospitals, millions of patient hours and 100% electrophysiologist approval are unsourced marketing claims
Setup & Integrations
Technical difficulty
Very low for the patient and effectively nil for the clinician. The patch is adhesive, has no cables, needs no charging and streams automatically once paired through the mobile app; nothing has to be configured beyond accepting the terms and giving a mobile number. Clinicians work from a browser-based cloud dashboard with no installation. The real effort is contractual rather than technical: a prescription, a billing and insurance pathway, and equipment return logistics. Since no API or EHR integration is offered, there is also nothing to implement, which removes setup work and any option to integrate.
Deployment
Apps stores
Behind SmartCardia
Fundraising
Social
Resources
All the official URLs gathered for verification and reference.
Frequently asked questions
How many ECG leads does the SmartCardia patch record?
How long can the patch be worn?
Which monitoring modes does one patch cover?
What is the regulatory status of the device?
Which certifications does SmartCardia hold?
How much does SmartCardia cost?
Is a prescription required, and is there an age limit?
Does SmartCardia offer an API?
Does the service replace medical advice or emergency care?
Is there a mobile app?
Should you pick SmartCardia?
SmartCardia is a clinical instrument rather than a consumer product or a self-service SaaS, and it should be judged on that basis. Its differentiators are concrete and checkable: seven ECG leads instead of the one to three usual on wearable patches, analysis of the entire recording rather than event extracts, and a single device covering Holter, extended Holter, event monitoring and mobile cardiac telemetry with remote switching between them.
The regulatory file is the strongest part of the offering. FDA clearance for outpatient cardiac telemetry, earlier clearances for the other monitoring modes, CE Class IIa approval in Europe, and ISO 13485 and ISO 27001 certificates published in full are all verifiable claims. The December 2024 acquisition of an accredited US diagnostic testing facility means the company now controls device, software and diagnostic service in a single chain, which matters for turnaround time and accountability.
The weaknesses are those of disclosure rather than of the product. No price is published anywhere, so any evaluation begins with a sales conversation. No API, no named integration and no documentation mean the platform cannot be assessed technically from the outside. Nothing is said about where patient data is hosted, no subprocessor list exists and no data processing agreement is offered, all of which a hospital procurement or data protection team will have to raise directly. The US terms carry a mandatory arbitration clause, a class action waiver and a liability cap of 100 USD.
The practical conclusion is that this is a purchase for a cardiology department or a health system, evaluated jointly by clinicians, procurement and legal, and not something an individual can try. The clinical and regulatory substance appears genuine; the commercial and technical disclosure is thin, and those gaps are worth putting in writing before signing.
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