How are you taking part in this consultation?

You will not be able to change how you comment later.

You must be signed in to answer questions

  • Question on Consultation

    • Has all of the relevant evidence been taken into account?

  • Question on Consultation

    • Are the summaries of clinical and and cost effectiveness reasonable interpretations of the evidence?

  • Question on Consultation

    • Are the recommendations sound and a suitable basis for guidance to the NHS?

  • Question on Consultation

    • Are there any equality issues that need special consideration and are not covered in the medical technology consultation document?
The content on this page is not current guidance and is only for the purposes of the consultation process.

KardiaMobile for detecting atrial fibrillation

Closed for comments This consultation ended on at   Request commenting lead permission

2 The technology

Technology

2.1 KardiaMobile is a portable electrocardiogram (ECG) recorder for detecting atrial fibrillation (AF). It is available as a single-lead or 6-lead (KardiaMobile-6L) ECG recorder. The single-lead device has 2 electrodes on the top surface. The person places 2 fingers on each electrode to take their ECG. KardiaMobile-6L has 3 electrodes; 2 on the top surface and 1 on the bottom which is placed on the left leg. People must keep still and must keep touching the electrodes for at least 30 seconds for a complete recording to be taken.

2.2 KardiaMobile works with a compatible smart mobile device to run the Kardia app. While taking a reading, the ECG recording is sent wirelessly to the mobile device where it can be viewed in the app. The app shows the ECG trace and the classification as either normal, possible AF, tachycardia, bradycardia, or unclassified. Traces may also be classified as unreadable if the ECG data cannot be interpreted because of possible interference. ECG data can be saved as a pdf file and emailed to healthcare professionals.

Innovative aspects

2.3 KardiaMobile is easy to use, it is compact and can be used anywhere, at any time of the day, to record an ECG. ECG recordings can be made available to healthcare professionals as soon as they are taken rather than at the end of a specified monitoring period.

Intended use

2.4 The KardiaMobile heart monitor and Kardia app is intended for adults to detect abnormal heart rhythms. This guidance focuses on using KardiaMobile for detecting AF in adults referred for ECG monitoring. KardiaMobile would be prescribed by a healthcare professional for people who are experiencing arrhythmia symptoms. The healthcare professional will advise on the frequency and length of use. The instructions for use state that all interpretations of ECG recordings should be reviewed by a healthcare professional and used to support clinical decision making.

Relevant pathway

2.5 NICE's guideline on atrial fibrillation recommends that people with suspected AF have manual pulse palpations to detect an irregular pulse. If an irregular pulse is then detected, an ECG such as a 12-lead ECG is done. If an irregular pulse is then undetected by a 12-lead ECG recording an ambulatory monitor, event record or other ECG monitors should be done whether or not the person has symptoms.

Costs

2.6 The cost of single-lead KardiaMobile is £82.50 (excluding VAT) The Kardia app is free of cost.

For more details, see the website for KardiaMobile.