The CardioWatch 287-2 is a state-of-the-art wearable device engineered to intermittently monitor
non-inasive blood pressure (NIBP) with high accuracy. Accurate NIBP monitoring is essential for
managing various health conditions, including hypertension and cardiovascular diseases, and
provides critical data during perioperative care. Wearable technology such as the CardioWatch 287-2
offers a convenient and non-invasive method for continuous monitoring, significantly enhancing
patient outcomes and providing invaluable data for healthcare providers.

Blood pressure (BP) is a vital indicator of cardiovascular health, and its frequent and accurate monitoring can facilitate early detection of hypertensive disorders, guide therapeutic interventions, and prevent complications associated with cardiovascular diseases. Traditional BP measurement methods, such as the use of manual cuffs and arterial lines, while accurate, are often cumbersome, invasive, and impractical for continuous use. The CardioWatch 287-2 addresses these limitations by offering a seamless, non-invasive solution that can be integrated into daily life without discomfort or disruption.

To validate its NIBP algorithm, several clinical studies were conducted across diverse populations, comparing its performance against established reference devices such as arterial line recordings, automated cuff measurements, ambulatory blood pressure monitoring (ABPM), and manual auscultation. These studies aimed to assess the device’s accuracy, reliability, and consistency across various conditions, including resting and active states, different body positions, demographics, and health conditions. The validation process involved rigorous testing under controlled clinical settings and real-world scenarios to ensure the device’s performance is both reliable and robust. The following sections summarize the findings from these extensive validation studies.

Study Summaries

Study Centre: Reinier de Graaf Gasthuis, Delft, the Netherlands
Study Period: October 2022 – February 2023
Publication: DOI: https://doi.org/10.1093/ehjdh/ztae006
Study Population: 97 patients at rest undergoing awake cardiac catheterization
Reference Device: Arterial line
Population Characteristics:
- Age: 67 ± 11 years
- Female: 33 (33%)
- BMI: 27.4 ± 4.5 kg/m²
- Skin type: I-VI
- Clinical BP (systolic / diastolic): 144.2 ± 21.2 mmHg / 81.6 ± 13.0 mmHg
Measurement Pairs: 420 epochs (30 seconds)
Results:
- Systolic: ≤100 mmH in 48 samples (11%) and ≥160 mmHg in 106 samples (25%);
- Diastolic: ≤70 mmHg in 222 samples (53%) and ≥85 mmHg in 99 samples (24%);
- Mean error (systolic / diastolic): ±3.7 (SD ± 4.4) mmHg / ±2.5 (SD ± 3.7) mmHg
- Correlation (systolic / diastolic): R = 0.985 / R = 0.961
- Bias (systolic / diastolic): -0.17 mmHg / 0.2 mmHg
- 95% LoA (systolic / diastolic): -8.74 to 8.4 mmHg / -6.96 to 7.37 mmHg

Conclusion

The comprehensive validation studies conducted on the CardioWatch 287-2 confirm that its NIBP algorithm delivers highly accurate and reliable intermittent NIBP measurements across diverse populations and conditions. The results consistently demonstrate low mean errors and standard deviations, indicating strong agreement with reference measures such as arterial line recordings, automated BP cuffs, ABPM devices, and manual auscultation. The MULTI-VITAL study, performed at Reinier de Graaf Gasthuis, validated the device’s accuracy in a clinical setting during cardiac catheterization, This underscores the device’s precision in high-stakes medical environments, making it suitable for monitoring patients with critical health conditions. These findings collectively demonstrate the CardioWatch 287-2’s robust performance across various BP levels. The mean error and standard deviation remain consistently below 4 mmHg and 5 mmHg, respectively, validating the device’s capability to provide precise and consistent NIBP readings. Additionally, the CardioWatch 287-2’s accuracy across different demographic groups, including both genders and various skin types, reinforces its versatility. The CardioWatch 287-2’s ability to provide real-time, accurate NIBP data can aid in the early detection and monitoring of hypertension, guide clinical decision-making, and optimize patient monitoring. Its ease of use and non-invasive nature make it an accessible tool for a wide range of users, promoting better health outcomes through enhanced monitoring and timely interventions. In conclusion, the validation studies strongly support the CardioWatch 287-2 as a reliable and precise tool for intermittent NIBP monitoring. Its consistent performance across various conditions and populations underscores its potential for improving health outcomes through better monitoring and early intervention.