American Heart Association Issues Caution on Cuffless Blood Pressure Devices, Citing Need for Validation

The American Heart Association has issued a scientific statement cautioning against the use of cuffless blood pressure devices for medical diagnosis or treatment guidance, despite their growing popularity and convenience. Published in the Association's journal Hypertension, the statement emphasizes that these technologies require more rigorous validation before they can be safely integrated into clinical practice or trusted for home monitoring.

Cuffless devices, including smartwatches, rings, patches, and fingertip monitors, have proliferated over the past decade, offering the potential for frequent or continuous blood pressure monitoring during daily activities and sleep. However, the statement notes that the commercialization of these devices has outpaced the scientific evidence supporting their accuracy. Many personal wearable devices have not been validated for real-world conditions such as exercise, sleep, daily activity, or after taking medications that affect blood pressure. Variables like arm position, skin color, and calibration timing can also lead to inaccurate readings.

The statement aligns with recommendations in the 2025 AHA/ACC High Blood Pressure Guideline, which advised against using cuffless devices for diagnosis or treatment until they demonstrate greater precision and reliability. High blood pressure affects nearly half of U.S. adults—approximately 122 million people—and is the leading modifiable risk factor for cardiovascular disease, including heart attack, stroke, and heart failure, as well as kidney disease and cognitive decline. Globally, hypertension impacts an estimated 1.4 billion adults, with two-thirds residing in low- and middle-income countries.

Dr. Jordana Cohen, chair of the statement writing group, highlighted the confusion among clinicians and patients regarding how these devices work and whether their readings can be trusted. "Without proper validation, readings from cuffless blood pressure devices are not reliable sources to inform treatment decisions or evaluate interventions," Cohen stated. "Patients may receive incorrect diagnoses or inappropriate medication adjustments based on inaccurate data." The statement warns that unvalidated devices, which may produce a high volume of readings in novel settings, could lead to false reassurance or unnecessary alarm without established thresholds linked to cardiovascular outcomes.

The statement outlines several limitations and considerations for the future integration of cuffless technologies. It notes that while some devices have received clearance from the Food and Drug Administration (FDA), such clearance does not require formal accuracy testing under a standardized protocol. Up to 80% of blood pressure devices sold globally have never undergone formal validation testing, with cuffless devices showing even lower rates. The writing group calls for standardized validation protocols that reflect real-world use, including during medication intake, exercise, and sleep. Accuracy, access, and affordability must be prioritized, with attention to potential inaccuracies related to skin color and issues of connectivity.

Transparency and privacy protections are also critical, according to the statement. Manufacturers should disclose how algorithms generate readings, calibration frequency, and how patient data are stored and protected. Devices must clearly indicate whether readings reflect absolute blood pressure or changes relative to calibration to avoid misinterpretation. If validated, cuffless technologies could expand hypertension screening and treatment in under-resourced communities, but coordinated efforts in research, regulation, and public education are essential. The Association maintains a list of validated blood pressure devices for reference.

In summary, while cuffless blood pressure devices hold transformative potential for hypertension care, their current limitations necessitate caution. The statement underscores the need for more research to assess accuracy, long-term performance, and real-world utility before these tools can be reliably used in healthcare settings. As Cohen concluded, "Cuffless blood pressure devices have the potential to transform hypertension care when their accuracy and reliability improve. Clear standards and coordinated efforts are essential to ensure that innovation enhances, rather than compromises, cardiovascular care."