Technology Backed by Scientific Studies

Information, researches, scientific papers and clinical studies from international health agencies and accredited institutions.

Piezoelectric Sensor for the Monitoring of Arterial Pulse Wave: Detection of Arrhythmia Occurring in PAC/PVC Patients.

Sensors 2021.

An Arterial Compliance Sensor for Cuffless Blood Pressure Estimation Based on Piezoelectric and Optical Signals.

Micromachines 2022.

A Hemodynamic Pulse Wave Simulator Designed for Calibration of Local Pulse Wave Velocities Measurement for Cuffless Techniques.

Micromachines 2023.

Assessment of a calibration-free method of cuffless blood pressure measurement: a pilot study.

IEEE Journal of Translational Engineering in Health and Medicine, 2022.

Calibrating Oxygen Saturation Measurements for Different Skin Colors Using the Individual Typology Angle.

IEEE Journal of Translational Engineering in Health and Medicine, 2023.

Combining Local PWV and Quantified Arterial Changes for Calibration-Free Cuffless Blood Pressure Estimation: A Clinical Validation.

IEEE Sensors Journal, vol. 23, no. 1, 2023.

Clinical Trials

The most critical step to validate the performance, useability and safety of medical devices with international standards recognized by U.S. FDA., and eliminate possible issues before the release of our products.

International Standards Complied

ISO 81060-2: 2018

Demographics and characteristics

We covered multiple user groups include but not limited to: gender, age, and blood pressure.

Reference Sphygmomanometer

Welch Allyn DuraShock DS66 Trigger Aneroid

Measuring Procedure

The procedure used in this study follows ISO 81060-2:2018 Clause 5.2.4.1.1. By compare results of reference and subject device using sequential method repeatedly to gain 3 sets of valid readings from the same arm of the same patient to minimal external interferes and change in the patient's physiological condition. In order to be considered as a valid set of blood pressure readings, the differences between the reference and our device should be within 12 mmHg for systolic, and within 8 mmHg for diastolic.

Analysis Methods

Bland-Altman analysis

Pearson correlation

Passing Criteria

The complete validation procedures should be conducted in at least total of 85 subjects, as specified in the ISO 81060-2 standards, with at least 255 BP determinations having a mean error magnitude ≤ 5 mmHg and a standard deviation ≤ 8 mmHg.

Results

General Group: Pass
Specialty Group: Pass