Table 1.
Brand | Model | Target | Device Type | Functioning | Sensors Used | FDA Status |
---|---|---|---|---|---|---|
Abbot | Libre 2 [68] | Diabetes | Patch | Reading of blood glucose levels. | Intradermal Glucose Sensor | Approved (2020) |
AliveCor® | KardiaMobile [69] | Cardiology | Phone attachment | Reading the heart rate by positioning the fingers on the sensors | Electrodes | Clear (2014) |
Apple | Watch 6 [70] | General Purposes | Smart Watch | Reading the heart rate by positioning the fingers on the sensors. | Oximeter, Electrical Heart Rate Sensor, Optical Heart Rate Sensor, Accelerometer, Gyroscope | ECG Approved (2018)/Oximeter not Approved |
BACtrack® | Skyn™ [71] | Alcoholism | Bracelet | Measurement of alcohol levels. | - | Not Approved |
Dexcom | G5 Mobile [72] | Diabetes | Intradermal sensor | A sensor under the skin measures glucose levels. A transmitter attaches to the top of the sensor and sends the data wirelessly to a smart device. |
Intradermal Glucose Sensor | Approved (2015) |
Empatica | Embrace 2 [73] | Seizures | Smart Watch | Use machine learning (ML) to detect unusual patterns that are possibly associated with seizures. | EDA Sensor, Peripheral Temperature Sensor, 3-Axis accelerometer, Gyroscope | Approved (2018) |
Empatica | E4 [74] | General Purposes | Bracelet | It enables researchers to record physiological signals at home or in the laboratory. After recording, they can access the data for deep analysis. | PPG Sensor, 3-axis Accelerometer, EDA Sensor (GSR Sensor), Infrared Thermopile | Not Approved |
Fitbit | Versa 2™ [75] | General Purposes | Smart Watch | It monitors the heart rate, physical activity, sleep quality, oxygen saturation, and body temperature. | 3-axis accelerometer, optical heart rate monitor, altimeter, ambient light sensor, relative SpO2 sensor, built-in microphone | ECG app cleared (2020) |
Fitbit | Charge 4 [76] | Cardiology | Smart Watch | It monitors the heart rate, physical activity, sleep quality, oxygen saturation, and body temperature. | 3-axis accelerometer, optical heart rate monitor, altimeter | Not Approved |
Health Care Originals | ADAMM [77] | Asthma | Patch | It is worn discreetly under clothing. Follow-up of cough, breathing patterns, wheezing, heart rate, skin temperature, and activity level. | Acoustic, HR, temperature | - |
iRhythm | Zio® [78] | Cardiology | Patch | The physiological data collected for a predefined time interval is sent by mail to the provider, who generates reports for the patient and the doctor. | ECG | Clear (2021) |
Medtronic | Sensor Enlite™ [79] | Diabetes | Intradermal sensor | The sensor is inserted under the skin and captures glucose readings every 5 min, which it communicates wirelessly to the MiniMed pump or its Guardian system so that glucose levels can be observed in real-time. After 6 days, it is removed, discarded, and replaced with a new sensor. | Intradermal glucose sensing electrode | Approved (2016) |
Medtronic | Guardian™ Sensor 3 [80] | Diabetes | Intradermal sensor | Once inserted, it remains under the skin, capturing glucose readings every 5 min, sending them wirelessly to the MiniMed pump or its Guardian system so that glucose levels can be seen in real-time. After 6 days, it is removed, discarded, and replaced with a new sensor. | Intradermal glucose sensing electrode | Approved (2018) |
Orpyx® | Orpyx SI [81] | Diabetic foot | Foot Insoles | Custom insoles incorporate sensors to monitor pressure, step count, hours of wear, and temperature. Provides real-time audiovisual alerts and flushing instructions when sustained high-pressure levels occur. | Pressure sensors | Registered |
Oura | Oura Ring [82] | General Purposes | Finger ring | It uses a monitoring technology that collects the heart rate, heart rate variability, temperature, activity, and sleep quality from a non-invasive ring. | Body temperature sensor, optical, infrared sensors, and a 3D accelerometer and gyroscope | Not Approved |
Preventice | BodyGuardian® Heart [83] | Cardiology | Patch | Small wireless monitor that adheres to the chest via a disposable strip. The strip can be repositioned as needed due to its medical-grade adhesive and electrode gel and should be replaced periodically during the monitoring period. The monitor is returned to the service provider. | Accelerometer, ECG | Clear (2012) |
Sentio Solutions | Feel [84] | Emotional/mental health | Bracelet | A bracelet that monitors physiological signals throughout the day and learns to recognize emotional patterns. | EDA, PPG HR, skin sensor | - |
Zoll® | LifeVest® [85] | Cardiology | Vest | It is a portable cardioverter-defibrillator used by patients at risk of sudden cardiac death (SCD). It controls dangerously fast heart rhythms by applying an electric shock to the heart. LifeVest WCD is used directly against the patient’s skin. | Temperature sensor | Approved (2018) |
Xiaomi | Mi Band 5 [86] | General Purposes | Bracelet | It monitors heart rate, physical activity, sleep quality, oxygen saturation, body temperature, menstrual cycle. | ECG | Not Approved |
Withings | Move ECG [87] | Cardiology | Analog watch | In 30 s, a medical-grade ECG is ready by simply pressing the side button and placing a finger on the bezel. It can record an ECG with or without a phone nearby, as the data can be stored on the watch until the next sync. | Heart rate sensor, 3-axis accelerometer, 3-axis gyroscope | Not Approved |
Huawei | Band 6 [88] | General Purposes | Smart Watch | Measurement of oxygen levels in the blood through the use of LED clusters and photodiodes. Heart rate measurement. Sleep quality monitoring. | Accelerometer, three electrodes, ECG, barometric altimeter | Not Approved |
Holter | Stat-On™ [89] | Parkinson’s | Portable sensor | It is a non-invasive device worn on a belt that records the user’s motor status at all times of the day. | - | - |
Gyenno | Gyenno Spoon [90] | Parkinson’s | Spoon | By detecting involuntary hand movements, sensors activate internal motors that keep the spoon stable, helping the person eat normally. | Accelerometer | - |
Secmotic | Muvone [91] | Osteoporosis | Portable sensor | A device that checks if the activity carried out is appropriate to help strengthen bones or how much sun is needed to assimilate adequate amounts of Vitamin D. | - | - |