Lithuanian company Teltonika has received European CE MDR (Class IIa) certification for its TeltoHeart smart wristband, confirming its compliance with medical device standards.
The TeltoHeart smart wristband is designed to assist individuals with heart rhythm disorders and can detect various arrhythmias, including atrial fibrillation.
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It alerts users to abnormal heart rhythms, prompting them to conduct a six-lead electrocardiogram (ECG) using the device. This feature enables healthcare professionals to diagnose and treat conditions effectively.
The device combines photoplethysmogram (PPG) technology for long-term monitoring with an integrated six-lead ECG. It can detect atrial fibrillation, even amidst other cardiac irregularities.
Initially, the prototype algorithm for the device was developed by KTU (Kaunas University of Technology) researchers, with contributions from Vilnius University and Vilnius University Hospital Santaros Klinikos, and subsequently, the algorithm was refined by Teltonika Telemedic to meet telemedicine market demands.
The product’s launch is in line with the European Heart Rhythm Association’s (EHRA) 2022 recommendation for patients with infrequent cardiac arrhythmia symptoms to use certified wearable devices capable of performing ECGs or detecting arrhythmias with PPG technology, as an alternative to Holter monitoring.
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By GlobalDataTeltonika Telemedic CEO Martynas Osauskas said: “This is an important recognition that we have been working towards since the start of this project in 2020.
“The CE MDR certification proves that TeltoHeart is a safe and reliable product that delivers correct medical data. It allows our clients – medical institutions – and their patients to safely use the device to analyse data and make diagnoses.
“In addition, we will now be able to sell the TeltoHeart wristband in the European Union and many other countries around the world.”
Last year, Teltonika commenced mass production of the TeltoHeart smart medical wristband.
