A new scientific statement from the American Heart Association, published today in Hypertension, warns that cuffless blood pressure devices—such as smartwatches, rings, patches, and fingertip monitors—are not yet accurate enough to diagnose high blood pressure or guide treatment, despite their growing popularity. The statement, Cuffless Devices for the Measurement of Blood Pressure, supports the 2025 AHA/ACC High Blood Pressure Guideline, which recommended against using these devices for clinical decisions until they demonstrate greater precision and reliability.
The statement notes that nearly half of U.S. adults—about 122 million people—have high blood pressure (≥130/80 mm Hg), a leading cause of heart attack, stroke, heart failure, kidney disease, and dementia. Globally, an estimated 1.4 billion adults have hypertension, two-thirds in low- and middle-income countries. Cuffless devices could potentially improve access to monitoring, but their rapid commercialization has outpaced scientific validation.
“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 writing group chair Jordana Cohen, M.D., M.S.C.E., FAHA. “However, the speed of commercialization has outpaced the science.”
The devices use technologies such as photoplethysmography (measuring light absorption) or tonometry (measuring arterial force waves) to estimate blood pressure, often requiring calibration with a traditional cuff. However, up to 80% of blood pressure devices sold globally have never undergone formal validation testing; cuffless devices have even lower validation rates. FDA clearance does not require accuracy testing under standardized protocols, meaning regulatory approval does not guarantee measurement accuracy.
Key limitations include variable accuracy during exercise, sleep, or after taking blood pressure medications. Factors like arm position, skin color, and calibration frequency can also affect readings. Without proper validation, the statement warns that patients may receive incorrect diagnoses or inappropriate medication adjustments.
The statement calls for standardized validation protocols that reflect real-world use, including after medication, during physical activity, and sleep. It also emphasizes the need for transparency in how algorithms generate readings, calibration requirements, and data privacy. If validated, cuffless technologies could expand screening in under-resourced communities, but developers must address potential inaccuracies related to skin color, connectivity, and affordability.
“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 AHA advises users of cuffless devices to inform their doctors that home readings come from such devices and to use a validated cuff monitor for diagnosis or treatment decisions. A list of validated devices is available at validatebp.org.
