Table 1.
Device | Measurements (HR, ECG, Activity Hours, Temperature, Pulse Oximetry) | ECG Recording Duration | Regulatory Decisions/FDA Approval | Battery Life | Autodetect or Patient Triggered | Wear Location | Connectivity (Bluetooth, WiFi, Cellular) | Compatible OS |
---|---|---|---|---|---|---|---|---|
AliveCor Kardia mobile | ECG | 30 seconds | FDA cleared | Connected to smartphone | Patient triggered | Handheld | Bluetooth | iOS, Android |
Apple watch (Series 6) | HR ECG Activity Temperature Pulse oximetry |
30 seconds | Heart-tracking features are cleared by the FDA but the oxygen monitor is not | Charging | Patient triggered | Wrist | Wi-Fi, Bluetooth | iOS |
Beurer ME 90 | ECG | 30 seconds | FDA cleared | Battery | Patient triggered | Handheld | Bluetooth | N/A |
Bittium Faros | ECG HRV |
180 days | FDA cleared and CE marked | Rechargeable battery | N/A | Patch to the anterior chest or electrode | USB download | N/A |
Cardiac Designs ECG Check | ECG | 30 seconds | FDA cleared and CE marked | Rechargeable battery | Patient triggered | Handheld | Cloud server or email | N/A |
CardiBeat and HeartCheck ECG Pen | ECG | 30 seconds | FDA cleared and CE marked | AA battery | Patient triggered | Handheld | Information unavailable | |
CardioComm Solutions HeartCheck | ECG | 30 seconds | FDA cleared | AA battery | Patient triggered | Handheld | ||
COALA | ECG | Yes, 2 leads | FDA cleared | Rechargeable via charging station using wall adapter or USB | Patient triggered | Handheld | Wi-Fi, Bluetooth | iOS |
Eko DUO | ECG | Yes, single lead, 15, 30. 60, 120 seconds | FDA cleared | Charging | Patient triggered | Handheld | Wi-Fi, Bluetooth | iOS, Android |
Fitbit (Sense) | HR ECG Activity Pulse oximetry Temperature |
30 seconds | FDA cleared | Charging | Patient triggered | Wrist | Wi-Fi, Bluetooth | iOS, Android |
Garmin | Pulse oximetry Hydration HR |
No | N/A | N/A | N/A | Wrist | Wi-Fi, Bluetooth | iOS, Android |
Huawei (GT2 Pro) | HR ECG Activity Pulse oximetry Temperature |
Information unavailable | National Medical Products Administration’s Class II medical device registration certificate (Chinese) | Charging | Unavailable | Wrist | Bluetooth | Android, ECG function is not compatible with iOS, Windows |
MyDiagnostick | ECG | 60 seconds | Not cleared | Charged by USB | Patient triggered | Handheld | USB connection by the physician | N/A |
Omron HCG-801 | ECG | 30 seconds | FDA cleared | Battery | Patient triggered | Handheld | PC download | N/A |
Oura ring | HR ECG HRV Skin temperature Activity Respiratory rate |
Continuous | FDA cleared and CE marked | Battery | N/A | Chest | Bluetooth | iOS |
Qardiocore | Activity HR HRV Temperature |
No | Not cleared | Charging | Autodetect | Finger | Bluetooth | iOS, Android |
Samsung (Galaxy 3) | HR Pulse oximetry Activity ECG |
30 seconds | Cleared | Charging | Patient triggered | Wrist | Wi-Fi, Bluetooth | iOS, Android |
Smartphone ECG Devices | ||||||||
VitalPatch 7-day patch | Body temperature ECG HR HRV Accelerometer Body temperature |
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Vivalink 96-hour ECG patch | ECG HR RR Accelerometer |
96 hours to 7 days | FDA cleared | Battery | Unavailable | Patch to the anterior chest | N/A | N/A |
Whoop | HR Respiratory rate |
Information unavailable | FDA cleared | Charging | Autodetect | Wrist | Bluetooth | iOS, Android |
Withings Move ECG https://www.withings.com/move-ecg | ECG Activity |
30 seconds | ECG monitor of Move ECG has received a CE marking, following the medical device directive. Withings is working with the FDA to receive medical clearance. | Battery | Patient triggered | Wrist | Bluetooth | iOS, Android |
Withings ScanWatch https://www.withings.com/scanwatch | HR ECG Activity Pulse oximetry |
30 seconds | The Scan Monitor of the ScanWatch has received a CE marking for HR, ECG and SpO2 features following the medical device directive. Withings is working with the FDA to receive medical clearance. | Charging | Autodetect, patient-triggered | Wrist | Bluetooth | iOS, Android |
Xiaomi (Amazfit Smart Watch 2) | HR ECG Activity |
60 seconds | Not cleared | Charging | Patient triggered | Wrist | Wi-Fi, Bluetooth | iOS, Android |
Zenicor | ECG | 30 seconds | Zenicor’s system solution is CE marked Class IIa, and Zenicor Medical Systems AB is certified according to ISO13485. | Battery | Patient triggered | Handheld | Web-based service, Zenicor-ECG Doctor System | N/A |
Physician Prescribed Devices | ||||||||
BardyDx CAM Patch | ECG | Up to 14 days of extended Holter monitoring | FDA cleared and CE marked | 14 days | Autodetect, patient triggered | Patch to the anterior chest | Sent to physician | N/A |
BioTel Heart ePatch | ECG | ePatch 1-channel 14 days ePatch 3-channel 5 days |
FDA cleared and CE marked | 14 days | Autodetect, patient triggered | Patch to the anterior chest or electrode | Sent to physician | N/A |
BioTel Heart MCOT | ECG | Up to 30 days of near real-time continuous monitoring | FDA cleared | Rechargeable sensor and gateway | Autodetect, patient triggered | Patch to the anterior chest or electrodes or electrode | 4G data networking Sent to physician |
N/A |
Medilynx | ECG | Yes, 3 leads up to 30 days | FDA cleared | Self-applied | Autodetect | Attach the electrode to the anterior chest and put the device in the pocket | Wirelessly transmitted via nationwide carrier networks | N/A |
Boston Scientific Preventice Solutions |
ECG | Yes, may be up to 30 days | FDA cleared | Will be applied by physician or self-applied | Autodetect | Patch to the anterior chest | Sent to physician | N/A |
iRhythm Ziopatch/Zio XT/AT | ECG | Yes, up to 14 days | FDA cleared | Pre-charged in the mail and will be sent back by the patient | Autodetect but will be self-applied by the patient | Patch to the anterior chest | Sent to physician | N/A |
CE = Conformitè Europëenne; ECG = electrocardiogram; FDA = Food and Drug Administration; HR = heart rate; HRV = heart rate variability; N/A = not applicable.