The American Heart Association has issued a new scientific statement emphasizing that while cuffless blood pressure monitoring devices—such as smartwatches, rings, patches, and fingertip monitors—hold great promise for transforming hypertension care, they are not yet accurate or reliable enough for clinical use. Published in the journal Hypertension, the statement details the current limitations of these technologies and calls for more research and standardized validation protocols before they can be used to diagnose high blood pressure or guide treatment.
According to the Association, nearly half of U.S. adults—about 122 million people—have high blood pressure, defined as ≥130/80 mm Hg. Hypertension is the leading modifiable risk factor for cardiovascular diseases, including heart attack, stroke, and heart failure, as well as kidney disease and dementia. Globally, an estimated 1.4 billion adults have high blood pressure, with two-thirds living in low- and middle-income countries. The new statement supports the recently published 2025 AHA/ACC High Blood Pressure Guideline, which recommended against using cuffless devices for diagnosis or treatment until they demonstrate greater precision and reliability.
Dr. Jordana Cohen, chair of the statement writing group and associate professor at the Perelman School of Medicine at the University of Pennsylvania, noted, "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. However, the speed of commercialization has outpaced the science." The statement aims 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.
The number and variety of cuffless devices have increased significantly over the past decade. These technologies use different methods to detect cardiovascular signals, such as photoplethysmography (measuring light absorption) or tonometry (measuring arterial force waves). Some require calibration with a traditional arm cuff monitor, while others incorporate demographic information like age, sex, height, or weight. However, the statement warns that even FDA clearance does not guarantee measurement accuracy, as it 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 of validation.
Key limitations identified include the lack of validation for real-world use—such as during exercise, sleep, or after taking blood pressure medications—and the influence of variables like arm position, skin color, and calibration frequency. "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 added.
The statement outlines several considerations for integrating cuffless devices into care. First, standardized validation protocols are needed to ensure these devices meet the same criteria as traditional cuffed monitors. Second, accuracy, access, and affordability must be prioritized, particularly for under-resourced communities, with attention to potential inaccuracies related to skin color. Third, transparency and privacy protections are critical; manufacturers must disclose how algorithms generate readings, calibration frequency, and how patient data are stored and protected.
While cuffless technologies have the potential to expand hypertension screening and management, especially in low-resource settings, the statement emphasizes that they should not be used at this time to diagnose, track, or treat high blood pressure. Cohen advised, "If you currently have a smart watch, ring or other cuffless technology you are using to monitor your blood pressure, make sure your doctor is aware that any home readings you share are from this type of device and talk to them about using a validated device instead." A list of validated blood pressure devices is available at validatebp.org.
