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Teltonika’s TeltoHeart smart wristband gets CE MDR certification

Teltonika, a Lithuanian company, has obtained European CE MDR (Class IIa) certification for its TeltoHeart smart wristband, meeting medical device standards. This wristband integrates PPG technology for continuous monitoring and features a built-in six-lead ECG.

Tailored for individuals with heart rhythm disorders, TeltoHeart can detect various arrhythmias, including atrial fibrillation. It alerts users to abnormal heart rhythms, guiding them to perform a six-lead electrocardiogram (ECG) using the device, aiding healthcare professionals in diagnosis and management.

Initially developed by researchers from KTU (Kaunas University of Technology), with contributions from Vilnius University and Vilnius University Hospital Santaros Klinikos, Teltonika Telemedic further refined the algorithm to meet telemedicine market demands.

TeltoHeart's launch aligns with EHRA's 2022 recommendation, advocating for certified wearable devices capable of ECG monitoring or arrhythmia detection via PPG technology, providing an alternative to Holter monitoring for patients with infrequent cardiac arrhythmia symptoms.