CE-approval (Class IIa) for Heart2Save’s arrhythmia analysis service
Atrial fibrillation is a heart arrhythmia, which causes symptoms for some, but is asymptomatic for others. This means the person in question is often completely unaware of suffering from atrial fibrillation. The most feared consequence of atrial fibrillation is a cerebral stroke. In fact, atrial fibrillation causes no less than 40 % of cerebral strokes. The lifetime risk of a stroke is about 20 %.
AiVoni Analysis Service by Heart2Save has been certified as a medical device, which means it has gone through the same process as devices that are used in hospitals, ensuring product quality and patient safety. The Service’s clinically validated algorithms analyse the heart rhythm and send the response within seconds to the user. The service generates a diagnostic ECG report, which facilitates the initiation of a treatment path.
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.
Heart2Save collaborates with Suunto, a leading sports watch provider, in developing the product for arrhythmia detection. Heart2Save is responsible for the analysis service, and Suunto produces the ECG sensor. Suunto’s Movesense medical-grade ECG sensor is now in the final phase of medical device approval.
‘Congratulations for Heart2Save for medical approval. We will be there soon as well with the Movesense sensor and are looking forward to the success of Heart2Save’s product’, says Jussi Kaasinen, Director of Emerging Businesses, Suunto.
To expand the possibilities for stroke prevention, Heart2Save is now looking for new partners for ECG device integration.
On Nov 21-22.2019, Heart2Save is attending Slush, the world’s leading startup event, presenting the AiVoni Analysis Service, and is looking forward to meeting potential investors and other stakeholders. On Friday 22.11 the company can be found in the startup area, booth E8.
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Heart2Save’s mission is to save lives and ensure high life quality by early detection of heart arrhythmias and prevention of cerebral strokes. The company has developed AiVoni Analysis Service that allows users to identify heart arrhythmia anywhere, anytime. The service is certified as a medical device (CE 0537 / Class IIa). Heart2Save’s team consists of doctors, top medical signal processing PhD’s supported by medical device R&D, quality and regulatory professionals. The investor team adds expertise from business and financing perspectives. www.heart2save.com