Table 2.
Functionality characteristics per device (intermittent recording devices).
| Device | Manufacturer | Intended use | Recording time | Number of electrodes | Stand-alone | Source of clinical evaluation evidence | ||||||||||
| Handheld | ||||||||||||||||
|
|
Afib Alert | Lohman Technologies LLC | AFDa | <1 minute | 2 | Yes | PNDb | |||||||||
|
|
Beurer ME 80 | Beurer GmbH | ADc | <1 minute | 1 | Yes | —d | |||||||||
|
|
Cardea 3e | Human Medical Solutions Inc | AD | <1 minute | 4 | No | — | |||||||||
|
|
Cardio-B Palm ECGe | Shanghai International Holding Corp | M+Rf | <1 minute | 2 | Yes | — | |||||||||
|
|
Coala Heart Monitor | Coala Life AB | AFD | <1 minute | 3 | No | Clinical trials website and PND | |||||||||
|
|
ECG Checke | Cardiac Designs Inc | AD | <1 minute | 2 | No | PND | |||||||||
|
|
Eko DUOe | Eko Devices Inc | M+R | >1 minute | 2 | No | Clinical trials website and PND | |||||||||
|
|
Impulse ECG | — | — | <1 minute | 2 | No | — | |||||||||
|
|
Istel HR-2000e | Diagnosis SA | M+R | <1 minute | 4 | No | Clinical trials website | |||||||||
|
|
KardiaMobile | AliveCor, Inc | AD | <1 minute | 2 | No | Clinical trials website and PND | |||||||||
|
|
KardiaMobile 6L | AliveCor, Inc | AD | <1 minute | 3 | No | Clinical trials website and PND | |||||||||
|
|
KardiaMobile Card | AliveCor, Inc | AD | <1 minute | 2 | No | Clinical trials website and PND | |||||||||
|
|
MyDiagnostick | MyDiagnostick Medical BV | AFD | 1 minute | 2 | Yes | Clinical trials website | |||||||||
|
|
HeartCheck PEN | CardioComm Solutions, Inc | AD | <1 minute | 2 | No | PND | |||||||||
|
|
Zenicor-ECG | Zenicor Medical Systems | M+R | <1 minute | 2 | No | Clinical trials website | |||||||||
|
|
Heartscan HCG-801e | Omron | M+R | <1 minute | 3 | Yes | Clinical trials website | |||||||||
| Patch | ||||||||||||||||
|
|
VitalPatch RTMd | VitalConnect Inc | M+R | <1 week | 2 | Yes | PND | |||||||||
| Wearable | ||||||||||||||||
|
|
Nuubo ECG Vest | Nuubo Wearable Technologies | M+R | >1 week | 4 | Yes | Clinical trials website | |||||||||
|
|
SmartHearte | SHL Telemedicine International Ltd | M+R | <1 minute | 18 | No | PND | |||||||||
|
|
Apple Watch | Apple Inc | AFD | <1 minute | 2 | Yes | Clinical trials website and DNDg | |||||||||
|
|
Move ECGe | Withings | AFD | <1 minute | 2 | No | Clinical trials website and PND | |||||||||
|
|
Galaxy Active Watch (2 and 3)e | Samsung Electronics Co, Ltd | AFD | <1 minute | 2 | Yes | Clinical trials website and PND | |||||||||
|
|
Venu 2 Plus Smartwatche | Garmin Ltd | AFD | <1 minute | 2 | Yes | PND | |||||||||
|
|
Fitbit Charge 5 e | Alphabet Inc | AFD | <1 minute | 2 | Yes | Clinical trials website and PND | |||||||||
aAFD: atrial fibrillation detection.
bPND: Food and Drug Administration 510(k) Premarket Notification database.
cAD: arrhythmia detection.
dNot available.
eDevice found via internet search.
fM+R: measure and record electrocardiogram.
gDND: Food and Drug Administration 510(k) De Novo database.