CE-approval (Class IIa) for Heart2Save’s Arrhythmia Analysis Service
AiVoni Analysis Service by Heart2Save from Finland determines four different arrhythmias, allowing especially detection of atrial fibrillation. Early detection of arrhythmia significantly reduces the number of strokes caused by atrial fibrillation and thus saves lives and secures higher life quality. AiVoni Analysis Service is based on clinically validated algorithms and has now been certified as a medical device (CE 0537 / Class IIa). The service is available for ECG device providers through the industry-standard interface, Heart2Save is especially looking for new players in the consumer market, developing new innovative ECG solutions.
The algorithms have been validated in clinical studies, which proved that AiVoni Analysis Service can detect atrial fibrillation with high sensitivity (96 %) and specificity (99 %). Moreover, it can detect ventricular extrasystoles, bradycardia and tachycardia with high accuracy.