American Heart Association Warns Cuffless Blood Pressure Devices Not Yet Ready for Medical Use

The American Heart Association has issued a scientific statement cautioning that while cuffless blood pressure monitoring devices show significant potential, they are not yet accurate or reliable enough for clinical diagnosis or treatment guidance. The statement, published in the journal Hypertension, addresses growing confusion among both healthcare providers and patients about the role of these increasingly popular technologies.

Nearly half of U.S. adults, approximately 122 million people, have high blood pressure, a leading modifiable risk factor for cardiovascular disease, heart attack, stroke, and kidney disease. The convenience and capability for frequent monitoring offered by smartwatches, rings, patches, and fingertip monitors present a tantalizing opportunity to transform hypertension care, especially for expanding screening in under-resourced communities. However, the rapid commercialization of these devices has outpaced the necessary 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 Dr. Jordana Cohen, chair of the statement writing group. "However, the speed of commercialization has outpaced the science." The statement aligns with and provides further detail for the recent 2025 AHA/ACC High Blood Pressure Guideline, which recommended against using cuffless devices for diagnosis or treatment.

A critical issue is the lack of standardized validation. The statement notes that up to 80% of all blood pressure devices sold globally have never undergone formal accuracy testing, with cuffless devices showing even lower validation rates. Importantly, FDA clearance does not require such standardized accuracy testing, meaning regulatory approval does not guarantee measurement reliability. Many personal wearable devices have not been validated for real-world conditions like exercise, sleep, daily activity, or after taking medication that affects blood pressure.

Variables such as arm position, skin color, and calibration timing can also affect results, leading to potentially inaccurate readings. Without established thresholds linked to clinical outcomes like heart attack or stroke, the high volume of data from these devices may cause confusion, false reassurance, or unnecessary alarm. "Without proper validation, readings from cuffless blood pressure device are not reliable sources to inform treatment decisions or evaluate interventions," Cohen warned. "Patients may receive incorrect diagnoses or inappropriate medication adjustments based on inaccurate data."

The statement outlines a path forward, emphasizing that more research and evaluation are needed to prove these devices meet the same accuracy criteria as traditional cuff monitors. Testing standards must reflect real-world use. If validated, these technologies could significantly expand access to hypertension management. The writing group calls for prioritizing accuracy, addressing potential inaccuracies related to skin color, and ensuring transparency from manufacturers about how algorithms generate readings and how patient data is protected. A list of validated blood pressure devices is available at validatebp.org.

For now, the Association strongly advises that cuffless devices should not be used to diagnose, track, or treat high blood pressure. Patients using such devices are urged to inform their doctors that any shared readings come from a cuffless device and to discuss using a validated device for any measurements guiding medical decisions. The future of cuffless monitoring depends on clear standards and coordinated efforts in research, regulation, and public education to ensure innovation enhances, rather than compromises, cardiovascular care.