Table 1.
Functionality characteristics per device (continuous recording devices).
Device | Manufacturer | Intended use | Recording time | Number of electrodes | Stand-alone | Source of clinical evaluation evidence | ||
Patch | ||||||||
|
C3 Holter Monitora | Cortrium ApS | M+Rb | 1 week | 3 | Yes | Clinical trials websitec | |
|
Custo Guard Holtera | Custo Med GmbH | M+R+PMDd | >1 day | 4 | Yes | —e | |
|
D-Heart | D-Heart Srl | M+R | 1 day | 6 | No | — | |
|
DigiTrak XT | Koninklijke Philips NV | M+R+HRDf,g | 1 week | 5 | Yes | Clinical trials websitec and PNDh | |
|
DR400 Patch Holter | NorthEast Monitoring Inc | ERi+ADj | >1 week | 3 | Yes | PND | |
|
Beam ECG Mobila | IEM GmbH | M+R+ERg | >1 minute | 8 | Yes | — | |
|
Bittium Faros 180 | Bittium | M+R+ADg | >1 week | 2 | Yes | PND | |
|
H3+ Digital Holtera | Welch Allyn | M+R+AD | >1 day | 5 | Yes | PND | |
|
M-trace Mini ECGa | M4Medical | M+R+ADg | 1 minute | 4 | Yes | Clinical trials websitec | |
|
PocketECGa | Medicalgorithmics SA | M+R+AD | 1 day | 3 | Yes | Clinical trials websitec and PND | |
|
R.Test Evolution 4 | Novacor | AD | >1 month | 2 | Yes | Clinical trials website and PND | |
|
Cardio ID+ Digital Holter Recorder 153+ Series | Rozinn | M+R | >1 day | 3 | Yes | PND | |
|
SenseLinka | Temeco | AD+ER | >1 week | 5 | Yes | — | |
|
Zensor | Renew Health Ltd | AD | >1 week | 7 | Yes | Clinical trials websitec and PND | |
|
1AX Wearable Biosensora | LifeSignals Inc | M+R | >1 day | 6 | No | Clinical trials websitec and PND | |
|
ATPatch | Atsens | AD | >1 week | 3 | No | Clinical trials website and PND | |
|
BodyGuardian | Preventice Technologies Inc | AD | 1 day | 4 | No | Clinical trials website and PND | |
|
Cardea Soloa | Cardiac Insight Inc | AD | 1 week | 2 | Yes | Clinical trials websitec and PND | |
|
Cardio STAT | Icentia Inc | AD | >1 week | 2 | Yes | Clinical trials website | |
|
Nuvant Mobile Cardiac Telemetry Monitor | Corventis | AD+CDk | >1 week | — | — | Clinical trials websitec and PND | |
|
S-Patch Exa | Wellysis | M+R | >1 day | 2 | No | Clinical trials websitec | |
|
Tag ECGa | Welch Allyn | AD | 1 week | 2 | Yes | — | |
|
Trident Holter Patcha | TZ Medical Inc | M+Rg | 1 week | — | Yes | — | |
|
Zio XT | iRhythm Technologies Inc | M+R | >1 week | 2 | Yes | Clinical trials website and PND | |
|
CardioMem CM 3000-12BTa | GE Healthcare | AD | >1 day | 12 | Yes | Clinical trials website and PND | |
|
MCOTa | Koninklijke Philips NV | AD | >1 day | 4 | No | Clinical trials websitec | |
|
BardyDX CAMa | Bardy Diagnostics Inc | AD | >1 week | 2 | Yes | PND | |
Wearable | ||||||||
|
QardioCorea | Qardio Inc | M+R | 1 day | 4 | No | PND | |
|
CART-Ia | Sky Labs Inc | AFDl | 1 day | — | No | Clinical trials websitec | |
|
Hexoskin | Carré Technologies Inc | Researchg | >1 day | — | No | Clinical trials websitec | |
|
VitalJacket Holter | BioDevices SA | AD+CD | >1 day | 6 | Yes | — | |
|
X10X and X10Y | L.I.F.E. Italia Srl | — | 1 day | 8 | Yes | Clinical trials websitec | |
|
Master Caution | HealthWatch Ltd | M+R | — | 12 | No | Clinical trials websitec and PND | |
|
Zephyr | Medtronic | M+R | >1 day | 2 | Yes | PND |
aDevice found via internet search.
bM+R: measure and record electrocardiogram.
cNo results available.
dPMD: pacemaker detection.
eNot available.
fHRD: heart rate detection.
gData found via internet search.
hPND: Food and Drug Administration 510(k) Premarket Notification database.
iER: event recorder.
jAD: arrhythmia detection.
kCD: conduction disorder detection.
lAFD: atrial fibrillation detection.