Can cuffless blood pressure (BP) measuring devices change cardiovascular disease prevention and treatment?

Potentially, but research has yet to prove these wearable devices as accurate or reliable enough to do so, according to a scientific statement from the American Heart Association. The scientific statement was published recently in Hypertension.

Jordana B. Cohen, MD, MSCE, statement writing group chair, told Medscape Medical News that cuffless BP technologies are rapidly entering the consumer and clinical marketplace, but most have not been adequately validated for accuracy or real-world use.

“Clinicians and patients are already encountering these devices, so clear guidance was needed to outline what is known, what remains uncertain, and what must be established before they can be used safely in care,” said Cohen, who is an associate professor of medicine and epidemiology at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia.

Cuffless devices such as smartwatches, rings, patches, and fingertip monitors can provide frequent or continuous BP measurement, and their ease of use and accessibility have led to a growing number of patients using them.

According to the statement authors, cuffless devices are often portable and convenient and can be deployed in homes and community centers, among community health workers, and by individuals themselves.

“This accessibility eliminates the need for individuals to travel long distances to receive basic health screenings, making it easier for residents of rural areas, or areas with shortages of healthcare professionals, to monitor their out-of-office BP regularly,” the authors wrote. “Cuffless BP devices offer promise for expanding BP measurement in under-resourced communities.”

Validation Needed

Despite this promise, cuffless devices have several crucial limitations. They rely heavily on technology such as sensors, algorithms, and data transmissions, which may not always function optimally in resource-limited settings or areas with poor connectivity, the authors wrote.

While several of these devices are FDA-cleared, clearance does not mean they will prove accurate enough for clinical use, they added.

“Although the FDA reviews data on device performance, formal clinical validation testing that adheres to an established protocol is not required for a BP measurement device to receive FDA clearance,” the authors wrote. “Thus, regulatory clearance is not synonymous with measurement accuracy.”

Whereas arm cuff-based validation protocols have been available for decades, accuracy protocols for cuffless devices are only now starting to become available, the authors continued.

“They’re so different than anything we’ve had before,” Cohen said. “Instead of basically measuring a blood pressure, because there’s no pressure involved, it’s taking physiologic signals, waveforms, and trying to extrapolate a pressure from that. And so this can be heavily affected by a lot of things.”

Gerald J. Jerome, PhD, professor in the Department of Kinesiology at Towson University in Towson, Maryland, noted that many cuffless devices also have not been validated across populations.

“For example, validation is needed across a full range of skin tones (for devices using [photoplethysmography]), among those with arrhythmias, and among those who are pregnant,” said Jerome, who was not involved in writing the statement but was the vice chair of another 2025 technology-based scientific statement from the AHA.

“While the promise of blood pressure assessment during different activities, such as sleep, physical activity, and daily activity, is appealing, additional research is required to confirm the accuracy of these measurements across real-world conditions,” he said.

“Wearables may support patient engagement,” he continued, “but validated cuff-based blood pressure measurement remains the clinical standard.”

Applications for Practice

Jerome said clinicians should consider proactively asking patients about their use of wearable BP devices and help them interpret the readings appropriately.

“Providers can explain the limitations of cuffless devices and address any anxiety or false reassurance patients may experience when reviewing data from a cuffless blood pressure measurement,” he said.

Cohen agreed, stating that patients are often unaware of the limitations of cuffless devices or that they are distinctive from cuffed devices.

“I think with really careful validation, when we demonstrate that these devices can be accurate in the way that they’re intended to be used in the real world, that they could really become a very, very valuable tool in how we manage and diagnose hypertension,” she said.

Cohen and Jerome reported having no relevant financial relationships.

Brian Ellis is a freelance writer and editor who lives in Southwest Virginia. Additional reporting by Brian Owens, a freelance journalist who lives in New Brunswick, Canada.