The American Heart Association has issued a scientific statement warning that cuffless blood pressure monitoring devices, including smartwatches, rings, patches and fingertip monitors, are not yet proven accurate enough for medical diagnosis or treatment guidance despite their growing popularity. This caution comes as nearly half of U.S. adults, approximately 122 million people, have high blood pressure, which remains the leading modifiable risk factor for cardiovascular disease, heart attack, stroke, heart failure, kidney disease, cognitive decline and dementia.
According to the statement published in the journal Hypertension, these devices show great promise as alternatives to traditional arm-cuff monitors but require more research and standardized validation protocols before they can be safely used in clinical practice. The statement supports 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.
"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 statement writing group chair Jordana Cohen, M.D., M.S.C.E., FAHA. "However, the speed of commercialization has outpaced the science." The statement was developed to address growing confusion among clinicians and patients about how these devices work, what their readings mean and whether they can be trusted for medical decision-making.
Available technologies include devices using photoplethysmography or tonometry, with some requiring calibration with conventional arm cuff monitors. Although some devices have received Food and Drug Administration clearance, this does not guarantee measurement accuracy since FDA clearance for blood pressure devices does not require formal accuracy testing under a standardized protocol. Up to 80% of all blood pressure devices sold globally have never undergone formal validation testing for accuracy, with cuffless devices showing even lower rates of validation.
Significant limitations affect cuffless devices' reliability. Many personal wearable devices have not been validated for real-world use during exercise, sleep, daily activity or after taking medication that affects blood pressure. Variables like arm position, skin color and calibration timing can also affect results and contribute to inaccurate measurements. The clinical relevance of the massive amount of data these devices produce remains uncertain, particularly readings obtained during sleep and physical activity where blood pressure measurements were not previously performed.
"Without proper validation, readings from cuffless blood pressure devices are not reliable sources to inform treatment decisions or evaluate interventions. Patients may receive incorrect diagnoses or inappropriate medication adjustments based on inaccurate data," Cohen emphasized. Future research is needed to determine how cuffless device readings correlate with cardiovascular outcomes, such as heart attack or stroke, before these tools are used in health care settings.
The statement outlines several considerations for potential future integration of these technologies into care. Standardized validation reflecting real-world use conditions is essential, as is addressing accuracy, access and affordability issues. Developers must address potential inaccuracies related to skin color as well as connectivity and affordability concerns. Transparency and privacy protections are critical, with manufacturers needing to disclose how algorithms generate readings, calibration frequency and how patient data are stored, shared and protected at resources like https://validatebp.org.
High blood pressure affects an estimated 1.4 billion adults worldwide, two-thirds of whom live in low- and middle-income countries. If validated, cuffless technologies could expand hypertension screening, diagnosis and treatment among people in under-resourced communities. "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."
