New products for the identification and screening of arrhythmias are being developed at high speed all over the world. The consumer experience is vital, the products must be easy and practical to use in everyday life. Stylish design and ease of use play a significant role in how the consumer embraces the product in the long run. In wellness and sports products, the design is something that is self evident, but when talking about medical devices, the AiVoni 💗 Lumoava ECG-necklace is the starting point for a new era of self-monitoring.
"Heart2Save has strong roots in science, and our products are medical devices. They have thus gone through the same demanding process as devices used in hospitals, so the information they provide can be trusted. In order to catch an occasional arrhythmia or asymptomatic atrial fibrillation repeated measurements are required. The measurements are easily done with a device that you always have with you, like a piece of jewellery. A medical device, as a design product, also does not stigmatise the user as someone having a heart disease. These were the starting points for Heart2Save's and Lumoava's idea to make a necklace into a medical device", said Helena Jäntti, an emergency doctor and CEO of Heart2Save.
The research behind the ECG-necklace was first showcased at a scientific congress organised by the European Society of Cardiology (ESC) in May. According to study findings, the ECG-necklace produced ECG recordings with excellent quality, from where both cardiologists and AiVoni arrhythmia detection algorithms could reliably identify arrhythmia. In self-monitoring products, accurate AI-based analyses are necessary so that the consumer doesn't have to interpret the ECG him/herself. The results received widespread international attention. Enclosed a link to the press release by ESC.
The study examined the diagnostic accuracy of the ECG-necklace, in which a single-lead ECG is embedded into the pendant. The study enrolled 145 adults who used the necklace to measure their own heart rhythm. Participants simultaneously underwent a three-lead ECG recording as a "gold standard" comparison.
To measure their heart rhythm, users start an application on their smartphone then place the necklace pendant between the palms of their hands or between the palm and the chest for 30 seconds. Data are automatically sent to a cloud service and analyzed for atrial fibrillation using artificial intelligence (AI). Within a few seconds, the smartphone application displays the results of the analysis. An ECG report is also generated for physicians to confirm the diagnosis.
Two cardiologists analyzed all ECG readings without knowing the initial rhythm (i.e. they were blinded to the 3-lead ECG recordings and initial 12-lead ECG). Automated AI analysis of the necklace ECG was also performed.
The necklace produced ECG recordings with excellent quality to detect and diagnose atrial fibrillation (Afib). Afib diagnoses made by standard ECG measurement were also picked up by the necklace device with high accuracy, both the automated AI analysis and interpretation of the ECG report by a cardiologist.
Study author Elmeri Santala, a medical student at the University of Eastern Finland, said: “The necklace ECG is simple to use and allows repetitive self-monitoring of heart rhythm, thereby improving the likelihood of detecting atrial fibrillation. The ESC recommends screening for atrial fibrillation in people over 65 years of age and in those at high risk of stroke;1 automated analysis by the necklace ECG is well suited for this purpose. Diagnosis of atrial fibrillation should always be confirmed by a physician using the ECG report.”
"It was easy for Lumoava to start a collaboration with Heart2Save, as we share the same values and have the right combination of expertise and knowledge. We have 75 years of experience in designing jewellery and working with silver, so it has been truly inspiring to join forces in the challenging process of designing and manufacturing this innovative medical device. How to develop a beautiful piece of jewellery, which at the same time is a life-saving medical device? We listened to our hearts and accepted the challenge, and soon these unique AiVoni 💗 Lumoava necklaces will be manufactured in Kuopio", said Mikko Pessi, CEO of Saurum.
One of the major causes of stroke is unrecognised and untreated atrial fibrillation. Approximately 25 percent of all strokes are caused by atrial fibrillation. While it is the most common heart rhythm disturbance, atrial fibrillation is often symptomless and intermittent, making its detection and diagnosis challenging. Innovative methods for detection are therefore needed.