ECG Monitor used with Move ECG has received CE marking following the Medical Device Directive 93/42/EEC as amended by the 2007/47/EC.
The multicentric study took place at Centre Cardiologique du Nord (Saint-Denis, France) and Aixum Clinic (Aix-en-Provence, France).
The ability of Move ECG to accurately classify an ECG recording into AFib and sinus rhythm was validated in a clinical trial of 137 participants. Rhythm classification from a gold standard 12-lead ECG read by a cardiac electrophysiologist was compared to the rhythm classification of an ECG collected from the Move ECG.
The performance of ECG Monitor is measured in terms of the sensitivity to detect AFib and the specificity to detect a normal sinus rhythm:
- 54 patients were in Normal Sinus Rhythm according to the reference. ECG Monitor correctly identified 53 of them, giving a specificity of Sp = 98.1%.
- 57 patients were in AFib according to the reference, and ECG Monitor correctly classified 56 of them, giving a sensitivity of Se = 98.2%.