Consumer-grade ‘smart devices’ for detecting cardiac arrhythmias
Device | CE and FDA clearance | Validation | PPG monitoring frequency | Sensitivity, % | Specificity, % |
---|---|---|---|---|---|
FibriCheck6 smartphone camera app | Atrial fibrillation | Validated vs standard 12-lead ECG | Not applicable | 95.6 | 96.6 |
KardiaMobile10 ECG monitor | Single-lead and 6-lead ECG to detect bradycardia, tachycardia, and atrial fibrillation | Validated vs standard 12-lead ECG | Not applicable | 96.6 | 94.1 |
Apple Watch Series 69 | Irregular heart rhythm notification and ECG monitoring | Validated vs standard 12-lead ECGa | Intermittent (every 5 minutes) | 85 | 75 |
Garmin smartwatch8 | Garmin Venu 2 Plus model with ECG capability | Garmin Forerunner 945 model validated vs Holter monitoring | Continuous | 96.9 | 99.3 |
Samsung smartwatch7 | ECG capability | Active 2 model validated vs BioTech ECG patch | Intermittent or continuous (user defined) | 96.9 | 99.3 |
Fitbit9 | Detecting atrial fibrillation, with ECG capability | Fitbit Sense model validated vs standard 12-lead ECGa | Continuous in some models (eg, Fitbit Charge 5) | 66 | 79 |
Withings ScanWatch9 | Detecting atrial fibrillation using ECG functionality and measuring blood oxygen saturation | Validated vs standard 12-lead ECGa | Intermittent (every 10 minutes) | 58 | 75 |
↵a The BASEL Wearable Study (reference 9) also validated Samsung Galaxy Watch 3 and KardiaMobile against standard 12-lead ECG and demonstrated closely comparable sensitivity and specificity to the Apple Watch, Fitbit, and Withings ScanWatch.
CE = Conformité Européenne; ECG = electrocardiography; FDA = US Food and Drug Administration; PPG = photoplethysmography