Table 2.
The characteristics of cuffless devices for non-invasive continuous monitoring of blood pressure.
| Device, company name, country | Measurement technology, device location | Disadvantages | Validation* | Status of the device |
|---|---|---|---|---|
| T-Line system, Tensys Medical, United States | Applanation tonometry, arm | The need for calibration; charging the device | ISO 81060-2, ISO 81060-3, ISO/TS 81060-5 | Approved FDA and commercialized |
| Boppli, PyrAmes, United States | Capacitance, arm or leg | In newborns prone to pressure sores due to the pressure of medical devices, it is recommended not to leave the cuffs in place for a long time. | Clinical data are limited | R&D |
| Aktiia bracelet, Aktiia SA, Switzerland | Photoplethysmography, arm | The need for calibration; charging the device | ISO81060-2 | The device is still awaiting FDA clearance |
| Biobeat, Biobeat, Israel | Photoplethysmography, arm, thorax | The need for calibration; charging the device; the skin patch can only be used once, although the sensor is intended for multiple uses. | ISO 81060-2, ISO 81060-3, ISO/TS 81060-5 | Approved FDA and commercialized |
| ViSi Mobile, Sotera Wireless, United States | Pulse wave velocity; Pulse transit time; arm | Charging the device | ISO 81060-2, ISO 81060-3, ISO/TS 81060-5 | Approved FDA and commercialized |
| Somnotouch NIBP, Somnomedics GmbH, Germany | Pulse wave velocity; Pulse transit time; arm | Charging the device | It is recommended to use ISO guidance when validating cuffless BP devices. | SOMNOtouch NIBP have undergone validation according to European Society of Hypertension protocols |
| BPro, Health-Stats, Singapore | Pulse wave analysis, arm | The need for calibration; charging the device | ISO 81060-2, ISO 81060-3, ISO/TS 81060-5 | Approved FDA and commercialized |
| Senti-Cor-100, Sensifree (United States) | Photoplethysmography, finger | The need for calibration; charging the device | Certificate CE | Commercialized |
| SeismoWatch, Georgia Tech Research Institute and Northwestern University, United States | Photoplethysmography and seismocardiography; arm, thorax | The need for calibration; charging the device | Clinical data are limited | R&D |
*https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm. **ISO 81060-2 Third edition 2018-11 Non-invasive sphygmomanometers – Part 2: Clinical investigation of intermittent automated measurement type [Including: Amendment 1 (2020)]; ***ISO 81060-3 First edition 2022-12 Non-invasive sphygmomanometers – Part 3: Clinical investigation of continuous automated measurement type; ****ISO/TS 81060-5 First edition 2020-02 Non-invasive sphygmomanometers – Part 5: Requirements for the repeatability and reproducibility of NIBP simulators for testing of automated non-invasive sphygmomanometers.