Blood Pressure
Sonya Collins
While many patients may be drawn to cuffless BP devices for their simplicity and convenience, a review published in JAMA Cardiology urges caution.
“If patients express interest in these devices, pharmacists should advise them not to use them as they have not undergone appropriate validation,” said Eugene Yang, MD, study coauthor and a cardiologist at UW Medicine in Bellevue, WA. “Instead, they should be directed to purchasing a validated arm cuff device.”
The review, published April 23, 2025, also provides an overview of cuffless devices on the market and in the pipeline.
Nearly half of U.S. adults have hypertension, according to the CDC’s National Center for Health Statistics. As many as 30% may have prehypertension, defined as a reading of 120–129/>80 mm Hg. In addition to recommendations for medication, when indicated, and lifestyle changes, patients in these populations are advised to monitor their BP at home with an approved and validated BP cuff. But many patients find these devices inconvenient, uncomfortable, and generally difficult to use and may be drawn to seemingly simpler cuffless devices.
The landscape of cuffless devices
Cuffless devices on the market and in the pipeline span far beyond smartwatches with a BP function.
The JAMA review describes numerous innovative technologies that may one day be validated for clinical and personal use. Mobile phone technology currently in development estimates BP by measuring blood flow transdermally, a method called transdermal optical processing. Temporary graphene electronic tattoos—thin, flexible, temporary, skin-mounted devices made of graphene—can monitor various physiological signals. Also in development are chest patches, wearable ultrasound patches, glasses, rings, and even a toilet seat. The latter, a smart toilet, has sensors embedded in the seat, including an electrocardiogram, a photoplethysmogram, and a ballistocardiogram.
Yang said, “The most progress has been made on wrist-worn devices as many companies are currently working on them.” FDA approved the first wrist-worn cuffless BP monitor on July 9, 2025, and the Hilo Band is expected to hit the American market next year.
Addressing a need
These emerging devices address a clear need in BP management. BP cuffs are far from perfect for personal, nonclinical use.
According to Yang and fellow researchers, just 3% of patients use these devices correctly. Sixty percent of users make three or more mistakes when attempting to use them. The most common mistake, made by three in four patients who commit errors, is incorrect cuff placement.
Many of these patients may benefit from and prefer cuffless technology. Further, cuffless BP monitors may be useful in certain clinical cases.
The research team outlined a few examples of these cases in the JAMA review, such as:
- A patient with white coat syndrome or other causes of an uncertain hypertension diagnosis with a cuff.
- A patient with a very large or very small arm or other cause of suspected inaccurate readings with a cuff, such as significant arrhythmia.
- Hospitalized or high-risk patients who need close BP monitoring.
Validation challenges
While cuffless BP monitoring technology is needed, the latest devices are not ready to replace the traditional ones yet.
Current guidelines for validation of traditional BP cuffs were developed jointly in 2018 by the Association for the Advancement of Medical Instrumentation, the European Society of Hypertension, and the International Organization for Standardization. These guidelines, however, cannot be applied to cuffless devices. While cuffs measure BP through sphygmomanometry, the various cuffless devices on the market and in the pipeline employ different methods to measure BP. Further, some are continuous BP monitoring devices, and others are not.
Several organizations have recently published validation protocols for cuffless devices. They do not yet address all the challenges of validating these devices, nor do these protocols apply to every type of cuffless device. As the protocols are new, there has not yet been sufficient time for all available devices to be tested.
Though cuffless BP technology for personal use may be a reality in the near future, it is not time yet. In the meantime, Yang said, “Pharmacists are trusted members of the clinical team. They should direct patients to validated arm cuff devices.”
They can be found at validatebp.org in the United States. ■