Clinical Trials

Inclusion Criteria:

• Females and Males subjects 18 years or older (from all skin tones/colors)

• Scheduled for ABPM for hypertension screening, evaluation, or management.

• Subjects capable of using an application temporarily downloaded (for the duration of the study) on a personal smart phone device or on a device provided by the study sponsor.

• Subjects with Atrial fibrillation or Atrial flutter are elligible to participate if standard cuff-based ABPM monitor can capture blood pressure at initialization.

Exclusion Criteria:

• Indication for ABPM is orthostatic hypotension or POTS (postural orthostatic tachycardiac syndrome) as indicated on the ABPM referral order.

• Any neurological, psychological, or other condition impairing the ability to provide informed consent or participate in the study.

• Inability to reliably access the Internet via a smart phone.

• Not able to perform standard cuff-based ABPM.

• Average absolute difference between the two arms is greater than 15 mmHg for SBP or greater than 10 mmHg DBP during the initialization/calibration phase.

• Subjects with known allergy to “stickers” or skin patches.

• Subjects with solid dark tattoos on the area where the PPG-based device is attached.

• Subjects who are unwilling to have their chest hair shaved, if needed, to install the device (the device uses stickers and needs to be in direct contact with the skin without hair)

• Subjects who are unwilling to comply with the study instructions (avoid vigorous exercise and showering for 24 hours while the device is in place)

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 9/05/2025. Questions regarding updates should be directed to the study team contact.