Medtech start-up Heart2Save has developed a product it claims will “revolutionise” heart rhythm self-monitoring — an AI-powered ECG necklace.
The firm worked with fellow Finnish company and jewellery maker Lumoava to create the AiVoni Lumoava device.
The necklace is designed to monitor a patient’s heartbeat in a subtle, fashionable way that doesn’t highlight they have a heart condition. Heart2Save has described this as “the starting point for a new era of self-monitoring”.
The device connects to Heart2Save’s mobile phone app, AiVoni, to analyse results from the monitor.
Evidence of the device’s effectiveness was recently published online by the European Society of Cardiology (ESC), which described it as “ingenious”, and found it was able to produce “excellent quality” ECG (electrocardiogram) recordings in a study involving 145 participants.
When compared to the gold standard for ECG monitoring, the necklace was also found to accurately detect and diagnose atrial fibrillation (AF) — a condition characterised by an irregular heartbeat rhythm, which is often unrecognised and causes approximately 25% of strokes.
Heart2Save is currently in the process of gaining a CE marking to sell the necklace in Europe and is aiming to reach this goal by Q4 2020.
Helena Jäntti, Heart2Save CEO and emergency doctor at Kuopio University Hospital, Finland, discusses her company’s device, and its potential in the field of at-home heart monitoring.
Q&A on self-monitoring ECG necklace
How does the user measure their heart rate with the device?
The necklace ECG device is a so-called “event ECG recorder”, so it does not monitor the heart or arrhythmias continuously.
The user can make an arrhythmia analysis once per day, for example, in order to catch symptomless atrial fibrillation — or whenever arrhythmia symptoms appear.
The ECG measurement is very easy to do; the user only needs to place the device between the palms of their hands, or between their chest and their palm, and start the ECG measurement from a mobile phone application.
Specifically, what does the device measure, and how are results from the necklace’s sensor shared with the patient?
The necklace is an event ECG recorder, so it makes the same ECG measurement that is used for arrhythmia diagnosis in healthcare.
The device detects four different arrhythmias: Atrial fibrillation, bradycardia [slow heart rate], tachycardia [fast heart rate] and ventricular ectopic beats.
The application collects 30 seconds of ECG and sends it to the arrhythmia analysis cloud service, where AI-based algorithms detect possible atrial fibrillation and other arrhythmias.
Within a few seconds after the measurement, the application shows the arrhythmia analysis results for the user.
The results are presented in a user-friendly format, with the arrhythmia name and a simple guide explaining what the arrhythmia indications mean — as well as what the user needs to do.
In addition, the cloud service generates an ECG report that physicians can use to make a final arrhythmia diagnosis.
The main idea for the AiVoni development team has been to develop a user-centred medical solution.
Therefore, the AiVoni for Android application and Heart2Save’s homepage include basic information of the different arrhythmias and instructions on how to act if an arrhythmia is recognised.
Users can become familiar with arrhythmias and instructions before the arrhythmia has even been detected.
Why is the necklace classed as a medical device, and are there any specific device regulations you’ve had to adhere to with this product?
The main thing is the intended use of the device. Since our intended use is arrhythmia detection, the whole product will be a medical device.
The main components of the product are a necklace-embedded single-lead ECG sensor, the AiVoni (by Heart2Save, Finland) mobile phone application and an analysing service in the cloud — which are all Class IIa medical devices.
The whole system, application, algorithms and ECG-sensor have gone through the medical device regulation process, including clinical validation.
Are there new features or improvements to the design, or technology, of the device on the way?
Of course, Lumoava will release a jewellery collection designed similarly to the AiVoni Lumoava necklace.
For example, earrings will be released shortly after the necklace. However, the arrhythmia analysis feature will only be in the necklace.
With the necklace ECG recording, it is also possible to make accurate heart rate and heart rate variability analyses.
In the future, it may be possible to add stress or recovery monitoring features.
From the same measurement that possible arrhythmias can be diagnosed, it is also possible to analyse things like user stress levels related to work or activity.
How important do you think the necklace could become in helping people monitor their heart rate outside of the healthcare setting?
The arrhythmia and stroke risk population in the western world is massive; almost 20% of the population in the EU and US has an increased risk for strokes.
Therefore, self-monitoring devices which enable early detection of arrhythmias and prevention of severe consequences, such as a stroke, are needed.
With the necklace, ECG arrhythmia monitoring is very cost-efficient because no healthcare guidance or resources are needed at all.
We strongly believe that elderly consumers who appreciate a healthy life are interested in monitoring their heart wellbeing with the device.
What do you think puts the necklace ahead of other heart monitoring medical devices available?
There are two major advantages in the necklace. First of all, the necklace is always with you.
No matter where or when arrhythmia symptoms appear, the necklace is available and diagnostic arrhythmia measurement can be done immediately.
Secondly, to be effective, users must incorporate arrhythmia monitoring devices into their everyday life.
It is evident that design plays a significant role in user adaptation. Therefore, a beautiful design can increase the usage of these devices over the long term, and increase the possibility of detecting silent arrhythmias.
In addition, many commercial health products are too technical and complicated for elderly consumers, who have the highest risk of arrhythmias and stroke.
We, at Heart2Save, have been focused on making this product so simple that everyone can use it.
What countries are you planning to sell the device in, and do you have any plans to expand this?
Our license to sell covers the EU. In the first phase, the supported languages will be Finnish, Swedish, English, and German, so we are planning to sell in countries that have one of these as an official language.
Of course, we have plans to expand further, but one step at the time.
