The American Heart Association's own December 2025 statement says the smartwatches and rings promising cuff-free blood pressure readings aren't validated enough yet to trust for diagnosis.
Not yet, by the American Heart Association's own account. Its December 2025 scientific statement found cuffless blood pressure devices, smartwatches, rings, patches and fingertip monitors among them, promising but not accurate or standardized enough to diagnose high blood pressure or guide treatment decisions.
What the AHA actually said
The statement, published in the AHA's own journal Hypertension in December 2025 and released alongside the 2025 AHA/ACC hypertension guideline, is the clearest institutional answer to this question so far. It concludes that cuffless devices are easy to use, convenient, and capable of frequent or continuous monitoring, real advantages over a traditional arm cuff, but that the technology has outrun the validation needed to trust it clinically.
"Cuffless blood pressure devices are easy to use, convenient and capable of frequent or continuous monitoring," said Jordana Cohen, MD, the University of Pennsylvania physician who chaired the statement's writing group. The catch, in her own words: "the speed of commercialization has outpaced the science."
Why FDA clearance doesn't settle it
A reasonable assumption is that if a device is FDA-cleared, its readings must be accurate. The AHA statement directly contradicts that assumption: clearance for a blood pressure device does not require standardized accuracy testing against a reference standard. A product can reach the market without ever being tested the way a validation protocol would test it. [[INLINE]] That's a meaningful distinction for consumers, because a device can be legally sold and still never have proven its readings are correct in the way clinicians need.
“The speed of commercialization has outpaced the science.”
The scale of the validation gap
The statement puts a number on just how widespread the problem is: up to 80% of all blood pressure devices sold worldwide, cuffless technology included, have never undergone formal accuracy testing under a standardized protocol, and cuffless devices specifically have even lower validation rates than traditional cuffs. Given that nearly half of US adults, about 122 million people, have high blood pressure, and an estimated 1.4 billion adults have it globally, that's not a niche gap. It's a gap sitting under a technology being marketed directly to the people who most need reliable numbers.
Why cuffless measurement is technically harder
Traditional cuffs measure blood pressure by directly applying and releasing pressure against an artery, a mechanical method that's been standardized for decades. Cuffless devices instead estimate blood pressure indirectly, often from pulse wave signals detected optically or through sensors, then run that signal through an algorithm calibrated against a reference reading. That indirect approach can drift over time, vary by skin tone, wrist position, or individual physiology, and needs extensive, standardized testing across diverse populations to prove it holds up. Most devices on the market haven't completed that process yet, which is exactly the gap the AHA statement is flagging.
This is the same validation gap that surfaced when WHOOP's blood pressure feature drew FDA scrutiny: a wearable company making a measurement claim the regulator hadn't actually confirmed. It's a pattern worth watching for across the wearable category generally, including in how much weight to put on other wearable metrics like HRV that promise more precision than the underlying sensors can currently deliver.
What the big brands are actually cleared to do
It's worth being precise about what's actually been cleared versus what's being marketed, because the two get blurred constantly in coverage of this category. Apple's hypertension notification feature was FDA-cleared on September 11, 2025, but that clearance covers an alert that flags a pattern suggestive of hypertension over time, not a direct blood pressure measurement the way a cuff produces one. Samsung's on-demand blood pressure feature is described by reporting on the AHA statement as a wellness feature rather than an FDA-cleared diagnostic device. Neither is the same claim as "this watch measures your blood pressure as accurately as a cuff," which is the claim the AHA statement is specifically pushing back on.
What to actually do instead
The AHA points people toward validatebp.org, a public list of blood pressure devices that have passed standardized, independent validation testing. If you're using a cuffless wearable now, the statement's practical advice is to keep using a validated cuff device for any reading that will actually inform a treatment decision, and to tell your doctor you're using a wearable so they can weigh its numbers appropriately rather than as a clinical data point.
Our take
Cuffless blood pressure tech is a genuinely promising direction, continuous, cuff-free monitoring would be a real advance in hypertension care. But "promising" and "ready to replace your cuff" are different claims, and the AHA's own scientific statement, written by the people building the hypertension guidelines, says this technology isn't there yet. Use it for trend curiosity, not for deciding whether your blood pressure is actually under control.
This is general information, not medical advice. Talk to a clinician before changing anything, especially if you are pregnant, nursing, or managing a condition.
Frequently asked questions
Are cuffless blood pressure watches and rings accurate?
Not reliably enough for medical decisions, according to the American Heart Association's December 2025 scientific statement. It found cuffless devices promising but says they lack the standardized validation needed to diagnose high blood pressure or guide treatment, and advises against relying on them for either.
Does FDA clearance mean a blood pressure wearable is accurate?
No. The AHA's statement specifically notes that FDA clearance for a blood pressure device does not require standardized accuracy testing. A device can be cleared for sale without having passed the kind of validation protocol that would confirm its readings are actually correct.
Which blood pressure devices are actually validated?
The American Heart Association points to validatebp.org, which lists blood pressure devices that have passed standardized, independent accuracy testing. Most of these are traditional cuff-based monitors rather than cuffless wearables, since far fewer cuffless devices have completed that validation process.
Can a smartwatch replace a blood pressure cuff?
Not yet, per the AHA's 2025 guidance. The statement recommends using validated cuff-based monitors for any reading that will inform a medical decision, and suggests wearable users tell their doctor they're using one so readings are interpreted with that context in mind.
Why are cuffless blood pressure devices hard to validate?
They typically estimate blood pressure indirectly, through signals like pulse wave characteristics, rather than measuring the direct pressure a cuff applies. That indirect method needs standardized, large-scale testing against real cuff readings across diverse users, which most devices on the market haven't completed.
How common is high blood pressure, and why does accuracy matter here?
Nearly half of US adults, about 122 million people, have high blood pressure, and an estimated 1.4 billion adults have it worldwide. Because so many people could be affected, the AHA stresses that an inaccurate reading, whether falsely reassuring or falsely alarming, has real consequences for treatment decisions.
Sources
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Statement highlights: cuffless blood pressure devices show great promise but lack validation, EurekAlert / American Heart Association