Cuffless Blood Pressure Devices Show Promise but Lack Accuracy for Clinical Use, Says Scientific Statement

Cuffless devices to measure blood pressure, such as smartwatches, rings, patches and fingertip monitors, show great promise as alternatives to traditional arm-cuff monitors, however, they are not yet proven accurate enough to diagnose high blood pressure or guide treatment decisions, according to a new scientific statement published in the American Heart Association's journal Hypertension. The statement provides an overview of available cuffless technologies and their potential future applications, while highlighting the notable limitations that need to be addressed before these devices can be used safely in clinical practice or as home monitoring devices.

According to the American Heart Association, nearly half of U.S. adults, about 122 million people, have high blood pressure, which is the number one modifiable risk factor for cardiovascular disease, including heart attack, stroke and heart failure. "Cuffless blood pressure devices are easy to use, convenient and capable of frequent or continuous monitoring, potentially providing insights into blood pressure changes during daily life and sleep," said Chair of the scientific statement writing group Jordana Cohen. "However, the speed of commercialization has outpaced the science."

The number and type of new wireless, personal devices available that state they are capable of measuring blood pressure have increased significantly over the past decade. These technologies include smartwatches, rings, patches and smartphone-based sensors that use light or force signals to estimate blood pressure. Although some devices are cleared by the Food and Drug Administration, careful consideration and continual monitoring of the measurement device's validation status is still essential before clinical use. FDA clearance for a blood pressure device does not require formal accuracy testing under a standardized protocol. Therefore, regulatory clearance does not guarantee measurement accuracy.

With these rapid technologic advances, device developers, clinicians and the public have struggled to keep up with methods of testing device accuracy, understanding the nuances of how different devices operate and what they are designed to estimate, and interpretation of the massive amount of data. Cuffless devices often produce a high volume of readings, many obtained in settings where blood pressure measurements were not previously performed, such as during sleep and physical activity. The clinical relevance of this data remains uncertain.

The statement writing group emphasizes that cuffless blood pressure devices should not be used at this time to diagnose, track or treat high blood pressure. Many personal wearable devices have not been validated for real world use, such as during exercise, sleep, daily activity or after taking medication that affects blood pressure. In addition, variables like arm position, skin color and how recently the device was calibrated, can also affect the results and contribute to inaccurate blood pressure measurements. "Without proper validation, readings from cuffless blood pressure device are not reliable sources to inform treatment decisions or evaluate interventions," Cohen said.

More research and evaluation are needed to prove these devices to be accurate and meet the same criteria as cuffed blood pressure devices. The testing standards will also need to reflect how these devices are used, particularly after taking medications that affect blood pressure, while exercising, sleeping or going about daily life. If validated, cuffless technologies could expand hypertension screening, diagnosis and treatment among people in under-resourced communities. Developers of these devices must address potential inaccuracies related to skin color as well as issues related to connectivity and affordability. Manufacturers must disclose how algorithms generate readings, calibration frequency and how patient data are stored, shared and protected.

"Cuffless blood pressure devices have the potential to transform hypertension care when their accuracy and reliability improve," Cohen said. "Clear standards and coordinated efforts in research, regulation and public education are essential to help ensure that innovation enhances, rather than compromises, cardiovascular care." The statement supports the recommendations in the recently published 2025 AHA/ACC High Blood Pressure Guideline, which recommended against using cuffless blood pressure devices for diagnosis or treatment until they demonstrate greater precision and reliability.