Top Things to Know: Cuffless Devices for the Measurement of Blood Pressure
Published: December 11, 2025
Prepared by Jordana B. Cohen, MD, MSCE, FAHA and Tammy M. Brady, MD, PhD
- Cuffless blood pressure (BP) devices offer convenience and aim to overcome discomfort and limitations of cuff-based devices, yet accuracy and clinical utility remain uncertain.
- Cuffless devices estimate BP indirectly. Most rely on sensors such as photoplethysmography (PPG) or tonometry, often combined with pulse transit/arrival time and machine learning. Outputs often represent BP change relative to calibration, not direct measurement.
- Calibration is a critical step. The majority of cuffless BP devices require regular calibration with a cuff-based device, and some require demographic inputs to provide BP readings; accuracy depends heavily on calibration quality, user skill in obtaining cuff-based measurements, cuff device accuracy, and recalibration frequency.
- Validation standards for cuffless BP devices are emerging. Protocols for cuffless devices providing continuous measurements were published in December 2022 but there is currently no International Organization for Standardization (ISO) protocol for cuffless devices providing intermittent measurements. Current ISO and the Institute of Electrical and Electronics Engineers (IEEE) standards do not fully capture real-world use conditions of devices meant for everyday use by a diverse group of people.
- Accuracy is particularly susceptible in real-world use. Device performance is highly susceptible to motion, sensor positioning, body posture, and hydrostatic pressure effects. Yet most validation occurs immediately after calibration in static, controlled settings—leaving true real-world utility unproven.
- Although some devices may be Food and Drug Administration (FDA) cleared, careful consideration and continual monitoring of the measurement device’s validation status is still essential before clinical use.
- Potential advantages are theoretical. Cuffless devices could enable BP monitoring during sleep, physical activity, other activities of daily living, and in populations with poor tolerance of repeated cuff inflation (e.g., children, hospitalized patients). However, with the large breadth of data obtained in scenarios in which BP was not previously routinely measured, robust accuracy and outcome evidence is needed for interpretation.
- Certain populations pose challenges. Device accuracy may vary by skin tone, age, body habitus, and health condition. Pediatric use in particular may require tailored validation protocols.
- Implementation in under-resourced settings has both potential and pitfalls. Devices may improve access where traditional monitoring is limited, but barriers include cost, connectivity, calibration requirements, and risk of misinformation.
- Key gaps must be addressed before clinical adoption. Priorities include standardized validation protocols, assessment of real-world utility, demonstration of calibration stability, evidence linking cuffless BP readings with outcomes, and safeguards for data privacy and interpretability.
Citation
Cohen JB, Byfield RL, Hardy ST, Juraschek SP, Houston Miller N, Mukkamala R, Picone DS, Thiele RH, Yang E, Brady TM; on behalf of the American Heart Association Council on Hypertension; Council on Cardiovascular and Stroke Nursing; Council on Cardiovascular Surgery and Anesthesia; and Council on Clinical Cardiology. Cuffless devices for the measurement of blood pressure: a scientific statement from the American Heart Association. Hypertension. Published online December 11, 2025. doi: 10.1161/HYP.0000000000000254