- Apple’s AI-powered hypertension alert: The latest Apple Watch Series 11 (with models back to Series 9) introduces a feature that notifies users of potential high blood pressure using AI analysis of sensor data reuters.com reuters.com. The watch does not directly measure blood pressure – instead it detects patterns over time and alerts the wearer to check with a traditional cuff if hypertension is suspected reuters.com.
- FDA-cleared but not a cuff replacement: Apple’s hypertension notification gained U.S. FDA approval in September 2025 reuters.com reuters.com, underscoring its safety. However, experts stress it’s only an early warning tool – users must confirm high blood pressure with standard monitors and doctors, as the watch provides no systolic/diastolic readings reuters.com reuters.com.
- Global rollout to combat a “silent killer”: Apple will roll out the feature in 150+ countries, potentially alerting over 1 million users in the first year to previously undiagnosed hypertension fiercebiotech.com fiercebiotech.com. High blood pressure affects ~1.3 billion people worldwide (with ~50% undiagnosed) reuters.com, so earlier detection via wearables could help prevent heart attacks and strokes reuters.com cardiovascularbusiness.com.
- Samsung’s head start (outside the U.S.): Samsung Galaxy Watch models since 2020 can measure blood pressure on demand via their optical heart sensors, but require monthly calibration with a cuff cardiowell.com cardiowell.com. This feature is available in many regions (e.g. South Korea, EU) but remained unapproved by the FDA as of early 2025, so U.S. users can’t officially use it yet bestbuy.com cardiowell.com.
- Cuff-based wearables exist: Other devices have tackled wrist BP by integrating inflatable cuffs. Huawei’s Watch D uses a tiny wristband cuff to provide calibration-free blood pressure readings – a world-first design notebookcheck.net notebookcheck.net. The Omron HeartGuide, launched in 2019, was the first FDA-cleared blood pressure watch, using a cuff in the strap for clinically accurate measurements healthline.com. These solutions give actual BP numbers but tend to be bulkier and pricier, underlining the trade-offs in accuracy vs. convenience notebookcheck.net healthline.com.
- Wearable BP tech is advancing, but use wisely: No smartwatch can replace a medical-grade blood pressure cuff yet healthline.com healthline.com. Experts praise the potential of continuous, cuffless monitoring to spur earlier care cardiovascularbusiness.com cardiovascularbusiness.com, but caution that false negatives or positives are possible. Users shouldn’t be falsely reassured if no alert appears – traditional check-ups remain crucial reuters.com.
Apple’s AI-Powered Blood Pressure Notification Feature
Apple has added a long-awaited hypertension notification to its wearable lineup, marking a significant milestone in consumer health tech. Starting with the new Apple Watch Series 11 (on sale as of September 2025) – and rolling out to recent models back to Series 9 and the Ultra 2/3 – the watch can passively alert users if they may have high blood pressure reuters.com reuters.com. Unlike a typical blood pressure monitor, the Apple Watch isn’t directly measuring your systolic or diastolic pressure. Instead, Apple’s algorithms analyze subtle signals from the watch’s optical heart rate sensor over time to detect patterns indicative of hypertension reuters.com reuters.com. The system runs in the background, reviewing 30 days of sensor data at a time, and if it consistently sees signs of elevated blood pressure, it triggers a “Possible Hypertension” alert on the watch reuters.com fiercebiotech.com.
How AI unlocked the feature: Apple’s health team leveraged artificial intelligence to make this possible. Sumbul Ahmad Desai, Apple’s VP of Health, revealed that Apple applied AI models to vast troves of existing Apple Watch sensor data (from over 100,000 participants in a multi-year heart & movement study) to search for digital biomarkers of hypertension reuters.com. Essentially, the AI sifted through heart rate waveform patterns and other metrics to find features correlating with high blood pressure readings that users had provided with traditional cuffs. After identifying promising signals, Apple validated the algorithm in a dedicated clinical study of 2,000 people to ensure it could accurately flag hypertension risk reuters.com. This data-driven approach allowed Apple to develop a feature that works with hardware already in watches (no new sensor needed) by extracting new insights from the photoplethysmography (PPG) signal – the same green-light pulse sensor used for heart rate.
FDA clearance and safety: In early September 2025, Apple quietly secured FDA clearance for what it calls the “Cardiovascular Machine Learning-Based Hypertension Notification” feature cardiovascularbusiness.com cardiovascularbusiness.com. This clearance indicates the FDA’s confidence that the alert is safe and can effectively prompt users to seek further evaluation. Notably, by positioning it as a notification (wellness feature) rather than a diagnostic or a cuff-like measurement, Apple navigated a path to approval that others hadn’t yet achieved cardiowell.com cardiowell.com. The watch doesn’t give you a blood pressure number – it simply says you might have hypertension and should verify with a proper device or doctor. This distinction likely helped regulators approve it as a low-risk aid, not a standalone medical device. Apple emphasizes that it’s “not a substitute” for a cuff reuters.com, and the FDA explicitly notes the watch’s alert is only a prompt for further testing, not a definitive diagnosis cardiovascularbusiness.com. In other words, it’s an early warning system – similar to how Apple Watch can flag irregular heart rhythms but isn’t formally diagnosing atrial fibrillation on its own.
When an Apple Watch wearer does receive a high BP alert, the on-screen advice is to measure blood pressure with a traditional cuff (at home or a clinic) and consult a healthcare provider reuters.com. This approach aims to catch the many people who have high blood pressure unknowingly. Hypertension is often called the “silent killer” because it usually has no symptoms, yet over time it dramatically raises risks of heart disease, stroke, and kidney failure cardiovascularbusiness.com. Apple cites that over 1 billion people globally have hypertension, and half of them are undiagnosed reuters.com – often because people don’t regularly check BP unless they feel ill. By baking an alert into a popular gadget people wear daily, Apple hopes to nudge users into early action. “Hypertension is the leading preventable cause of heart attack and stroke, yet millions remain undiagnosed,” notes Dr. Harlan Krumholz, a Yale cardiologist, in Apple’s news release. “Making accurate detection easy and part of daily life can help people get care earlier and prevent avoidable harm” medicaleconomics.com.
Global impact and rollout: Apple’s hypertension alert is not limited to the U.S. market. The company is launching it in over 150 countries across North America, Europe, Asia, and more reuters.com reuters.com. Regions including the U.S., EU, UK, Canada, Australia and others are on the list, suggesting Apple obtained any necessary regulatory clearances internationally as well. The feature was included in watchOS 26 (released mid-September 2025) and is available to users once they update their watch software on compatible models medicaleconomics.com. Apple expects that within the first year, at least 1 million users will receive a hypertension notification they might not otherwise have gotten, leading many to discover a chronic condition early fiercebiotech.com. Over time, this could prompt those people to improve their lifestyle or start treatment sooner, potentially reducing incidents of uncontrolled high blood pressure. American College of Cardiology chief innovation officer Dr. Ami Bhatt noted that catching hypertension early on such a scale could help reduce related heart attacks and strokes if followed up properly reuters.com cardiovascularbusiness.com.
Apple’s health arsenal grows: The new blood pressure alert joins an expanding suite of health features on the Apple Watch. Apple’s wearables already offer a single-lead ECG (electrocardiogram) for detecting atrial fibrillation, irregular heart rhythm notifications, high and low heart-rate alerts, blood oxygen saturation tracking, and features like fall detection and cycle tracking. The hypertension notification is a logical next step in Apple’s strategy to position the Watch as a proactive health monitor. It leverages the same optical sensor used for heart rate and oxygen to glean deeper insights (in this case, vascular stiffness or other blood flow clues related to blood pressure) fiercebiotech.com. By adding this feature, Apple Watch becomes more of an all-around cardiovascular watchdog – keeping an eye on heart rhythm, heart rate extremes, blood oxygen, and now blood pressure trends. Apple has indicated they were interested in blood pressure detection “for years” reuters.com, but they took time to research and “be careful to avoid false positives that might alarm users” reuters.com. This cautious approach shows in the feature’s design: it’s a long-term trend analysis rather than instantaneous reading, aiming for meaningful alerts rather than frequent misleading pings. Privacy was another factor: Apple’s strict on-device data handling meant they needed large voluntary studies to gather enough blood pressure data to train their AI reuters.com. Those studies paid off in a feature that works universally without needing new sensors or user calibration.
Users and doctors alike are intrigued by this development. It’s unprecedented for a mainstream smartwatch to get an FDA-cleared hypertension feature, and it underscores how far wearables have come. Still, doctors urge users to treat the watch as an adjunct, not a replacement for home blood pressure monitors or clinic checks reuters.com healthline.com. There is also a risk that someone with true hypertension might not get an alert if their patterns aren’t obvious enough in the 30-day algorithm – so no alert doesn’t guarantee you’re in the clear reuters.com. For that reason, Apple and cardiologists recommend that anyone with risk factors continue periodic traditional measurements. On the flip side, if your watch does buzz with a hypertension warning, it could be lifesaving if it prompts you to confirm a diagnosis and get treatment. As Dr. Bhatt cautioned, Apple must emphasize “the new feature is no substitute for traditional measurements and professional diagnosis” – it’s a nudge for preventive action, not the final word reuters.com.
Other Smartwatches and Wearables with Blood Pressure Monitoring
Apple’s entry into blood pressure tracking shines a spotlight on similar efforts by other tech companies. In fact, Apple was somewhat late to the game – rival wearables have touted blood pressure features for a few years, albeit with different approaches and limitations. Here’s how Apple’s blood pressure notification compares to other watches with this function:
- Samsung Galaxy Watch (Optical Sensing with Calibration): Samsung introduced a blood pressure feature in its Galaxy Watch lineup back in 2020 (starting with the Galaxy Watch 3) cardiowell.com. Samsung’s method also uses an optical heart-rate sensor (PPG) to estimate blood pressure, but with a crucial difference: it provides an actual systolic/diastolic reading on demand after the user calibrates the watch against a real cuff. To set it up, you must first measure your BP with a traditional cuff and input/sync that reading to the watch; the watch then adjusts its algorithm to match you. Re-calibration is required every 4 weeks to keep it accurate cardiowell.com. Once calibrated, you can open Samsung’s Health Monitor app and tap “Measure” to get an approximate BP reading anytime, with the watch using pulse wave analysis to estimate the pressure samsung.com samsung.com. Users in countries where it’s available have reported that the Galaxy Watch’s readings are reasonably close to cuff measurements initially, but can drift as weeks pass – hence the need to recalibrate monthly cardiowell.com. Importantly, in the U.S. this feature remains inactive on Samsung watches as of late 2025: “Blood pressure monitoring has yet to receive FDA approval for any Galaxy Watch, therefore this feature is not available in the US” Samsung’s support explains bestbuy.com. Samsung has obtained regulatory approval in South Korea and many regions in Europe/Asia, so international users can use it officially bestbuy.com. But gaining FDA clearance in the U.S. has proven tough – presumably due to strict accuracy requirements. In forums, some American Galaxy Watch owners have resorted to unofficial workarounds or third-party apps (like UCSF’s MyBP Lab) that attempted to enable BP readings, but these are not FDA-sanctioned and come with accuracy caveats bestbuy.com bestbuy.com. The bottom line: Samsung’s watches can output blood pressure numbers, giving users more information upfront than Apple’s alert, but they demand more effort (calibration) and carry greater uncertainty. Samsung’s approach essentially turns the watch into a complementary gadget to a real monitor – you need the latter to set up the former. By contrast, Apple’s approach needs no calibration or external device but only warns of possible hypertension, without telling you your precise pressure.
- Huawei Watch D (Inflatable Cuff Strap): A very different solution comes from Huawei. The Huawei Watch D, released in 2022, is a smartwatch designed from the ground up for blood pressure measurement. It contains a miniaturized inflatable cuff integrated into a slightly oversized watch band notebookcheck.net notebookcheck.net. When you trigger a reading, the strap pumps up around your wrist (you can even feel it tighten) and uses the standard oscillometric method – essentially just like a doctor’s cuff, but on your wrist – to determine your blood pressure. The big advantage is direct, calibration-free readings. In fact, Huawei touts the Watch D as the first wrist wearable that does not require regular calibration against an arm cuff notebookcheck.net notebookcheck.net, because it’s essentially a self-contained cuff itself. Reviewers found that it can produce readings in roughly a minute, and when used properly (watch at heart level, staying still) the results were within a few mmHg of a standard BP cuff in many cases. It even received regulatory approval in China and parts of Europe as a medical device. However, there are trade-offs. The Watch D is bulkier and more conspicuous than a typical smartwatch – the cuff mechanism adds thickness and weight (it weighs about 90 g with the strap, roughly double an Apple Watch) notebookcheck.net. Users also need to ensure the cuff strap is fitted correctly and may need to swap in a different strap size (Huawei includes two sizes) for an optimal fit notebookcheck.net. It’s also not widely sold in all markets (it’s not available in the U.S., likely awaiting FDA clearance or hampered by Huawei’s trade restrictions). For those who have access to it, the Watch D demonstrates an alternative philosophy: if accuracy is paramount, build the cuff into the watch. This approach can give medical-grade measurements (Huawei claims ±3 mmHg accuracy amazon.in), but it sacrifices some comfort and “wear-and-forget” convenience. It’s notable that Apple actually patented a similar idea of an inflatable watch band for blood pressure, but has not commercialized it yet cardiowell.com. That leaves Huawei’s Watch D (and a few niche startups) as the current examples of this cuff-in-a-watch concept.
- Omron HeartGuide (Clinical-Grade BP Watch): Long before Apple and Samsung joined the fray, medical device maker Omron released the HeartGuide in 2019 – essentially a digital wristwatch with a blood pressure cuff inside it. In fact, Omron’s HeartGuide was the first wearable to receive FDA clearance for blood pressure monitoring bimedis.com healthline.com. It’s a dedicated blood pressure watch: you press a button and an internal bladder in the strap inflates to take your blood pressure, then deflates. It reports the BP reading on its screen and logs it in a companion app. It can also track steps, sleep, and other basic fitness metrics, but it’s not a full-featured smartwatch (no touch screen, no third-party apps, etc.). The HeartGuide proved that wrist BP can be done accurately – it’s clinically validated and generally as reliable as at-home cuffs, since it uses the same method healthline.com healthline.com. However, it also highlighted challenges: the device is bulky and costly, around $500+, and the need to inflate a cuff means it’s not something you’d be doing constantly throughout the day. Consumer Reports actually noted that in their tests the HeartGuide’s usability issues led to it scoring lower than some standard blood pressure monitors consumerreports.org. Moreover, being a first-gen device, it wasn’t waterproof and had limited smartwatch functions healthline.com healthline.com. Omron has since focused on upper-arm cuffs with Bluetooth, but the HeartGuide remains on sale as a unique option for those who want a wearable, validated BP device. It shows the most straightforward way to measure blood pressure – put a real cuff on the wrist – is feasible, but it hasn’t achieved mass adoption due to practical limitations.
- Fitbit and others (research-phase solutions): Aside from Apple, Samsung, Huawei, and Omron, many others are exploring wearable blood pressure monitoring, though few have launched products yet. Fitbit (owned by Google) has been studying ways to measure blood pressure using its fitness trackers’ sensors. In 2022, Fitbit even launched a large study to test a pulse arrival time technique for blood pressure estimation medicalnewsbulletin.com. However, as of 2024/2025, Fitbit had not rolled out any BP feature in its devices, indicating the challenges involved medicalnewsbulletin.com. They have publicly said they’re still working on it and seeking regulatory approvals healthline.com. There are also startups like Aktiia, which sells a bracelet that continuously measures blood pressure using optical sensors (it’s available in Europe with a CE mark). Aktiia’s wristband checks BP multiple times per day when it detects you’re still, and uploads data to an app, but it too requires an initial calibration with a cuff and isn’t cleared by the FDA yet cardiowell.com. Another area to watch is smart rings: companies are researching ring-form devices that could measure blood pressure at the finger. None have hit the market with FDA approval so far, but experts believe a finger-based BP monitor may not be far off cardiowell.com. Finally, some less-known smartwatch brands (often from Chinese manufacturers) advertise blood pressure readings, but most of these are not medically validated – essentially they guestimate BP from heart rate variability or other crude methods, and should be viewed with skepticism healthline.com. Regulators like the FDA have held a high bar, demanding proof of accuracy and reliability before allowing marketing of such features in the U.S. cardiowell.com. Apple’s newly cleared feature is a notable breakthrough in this regulatory landscape, achieved by focusing on notification of trends rather than claiming to replace the cuff.
Opportunities and Challenges of Cuffless Blood Pressure Tech
The race to monitor blood pressure from the wrist (or other wearables) presents exciting possibilities – and significant hurdles. Hypertension is a huge public health issue, and easier monitoring could get more people aware of their condition earlier. Traditional blood pressure cuffs are effective but under-used; few people regularly carry a cuff or take readings at home. Smartwatches and fitness trackers, on the other hand, are worn for many hours a day by hundreds of millions of people. If those devices can even moderately accurately detect blood pressure changes, they could flag risks far sooner and more conveniently than occasional doctor visits. “The ability to continuously monitor blood vessel health from the wrist is a breakthrough for patients and healthcare professionals,” says Alexandra Murdoch, a senior medical analyst at GlobalData, adding that wearables are becoming “central” to healthcare delivery rather than just trendy gadgets cardiovascularbusiness.com cardiovascularbusiness.com. She and others see these tools as strengthening remote patient monitoring – doctors could eventually be remotely notified if a patient’s readings stay high, for instance, integrating with telehealth and chronic disease management cardiovascularbusiness.com cardiovascularbusiness.com. In that sense, Apple’s and Samsung’s BP features are part of a larger trend of consumer tech merging with healthcare, empowering people to keep tabs on health metrics continuously.
However, the quest for cuffless, accurate blood pressure measurement is technically challenging. Blood pressure is not like heart rate – you can’t directly “feel” or optically sense the pressure in arteries without some calibration or context. Factors like wrist position, artery depth, skin thickness, and even vascular stiffness make purely optical or sensor-based BP estimation difficult cardiowell.com cardiowell.com. Apple and Samsung’s use of the PPG (photoplethysmography) sensor essentially looks at the pulse wave characteristics; things like the time between the heart beat and when a pulse wave arrives at a peripheral site (pulse transit time) can correlate with blood pressure. But these signals are subtle and can be confounded by many variables. That’s why Samsung’s method needs frequent recalibration – it tries to learn your pulse signature when your BP is known and then detect changes. Apple chose a more cautious route: long-term trend recognition instead of instant readings, likely to minimize false alarms. By averaging data over 30 days, Apple’s algorithm smooths out day-to-day variability and looks for a persistent pattern, which might correlate better to true hypertension than any single measurement reuters.com cardiovascularbusiness.com. The trade-off is that Apple’s approach won’t catch a one-time spike (it’s designed for chronic hypertension, not immediate blood pressure spikes), and it won’t inform users who have borderline high BP unless it’s consistently elevated.
Accuracy and validation remain the elephants in the room. As of mid-2025, no wearable had been FDA-cleared to directly output blood pressure readings in the U.S. The FDA has set rigorous standards for any blood pressure claims, given that a wrong reading could be potentially dangerous (leading someone to take medication incorrectly or ignore a real problem) cardiowell.com. This is why Apple’s FDA-cleared feature stops short of providing numbers – it’s categorized likely as a low-risk notification, not a diagnostic. Samsung, despite years of data from markets abroad, still hasn’t convinced the FDA; they would need to show in a clinical trial that their watch readings are consistently accurate against gold-standard cuffs across a broad population. Small studies on smartwatch BP have shown mixed results healthline.com – some indicate promise, others highlight large errors. The consensus is that while wearables can track relative changes, getting absolute accuracy on par with a cuff is still hard without a physical pressure sensor. Experts like Yair Lurie, an engineer in the field of wearable BP, note that even multi-site measurements (like adding sensors in earbuds or rings to augment the watch) might be needed to improve precision cardiowell.com cardiowell.com. For now, companies are balancing how to deliver value to users without overstepping the tech’s limits. User education is key: consumers need to understand what the watch can and cannot do. As Healthline’s review of BP watches puts it, no wrist device can replace a proper upper-arm cuff for diagnosing or managing hypertension – at least not yet healthline.com healthline.com.
There’s also the issue of false reassurance vs. false anxiety. Dr. Ami Bhatt pointed out a critical perspective: if people rely on a watch to warn them, those who don’t get an alert might wrongly assume their blood pressure is fine reuters.com. On the flip side, if a device frequently misidentifies high BP (false positives), it could cause needless worry or doctor visits. Apple claims to have tuned its algorithms carefully to avoid false alarms reuters.com – likely preferring to miss some cases (better safe than sorry) rather than scare healthy users too often. Samsung’s approach of giving an actual reading could potentially lead to user confusion if the watch says, for example, 150/95 one day and 120/80 the next without clear explanation (as calibration drifts or wrist position changes). Ensuring users interpret these readings correctly is a challenge. That’s why both companies and doctors advise confirming any concerning values with a proper instrument. In our current state of the art, think of wearable blood pressure features as screening tools or wellness features – they can raise a red flag, but the diagnostic confirmation still relies on the tried-and-true cuff measurement cardiovascularbusiness.com.
Outlook: A New Era for Wearable Health, With Humans in the Loop
The arrival of blood pressure monitoring – even in notification form – on a mainstream smartwatch like Apple Watch Series 11 marks an inflection point for digital health. It signals that the tech giants believe their wearables are sophisticated enough to tackle ever more complex health metrics. Just as prior Apple Watch updates pushed ECGs to the masses and Samsung brought SpO₂ and even attempted sleep apnea detection on wrist devices, hypertension detection is becoming part of the wearable vocabulary. In the coming years, we can expect these features to expand and improve. Apple’s long game might involve eventually providing actual blood pressure estimates once they are confident in accuracy (they’ve explored wearable cuff prototypes in patents cardiowell.com). Samsung will likely continue refining its algorithm and may eventually gain FDA approval, which would open up its full feature set to U.S. customers. Other players like Google (Fitbit) are undoubtedly watching closely and will push their own solutions when ready.
Crucially, medical community acceptance will grow as evidence builds. The FDA’s clearance of Apple’s hypertension alert lends credibility – it’s a sign that regulators see benefit and reasonable safety in these innovations. Cardiologists are increasingly interested in how wearable data can complement traditional care. Some foresee doctors prescribing smartwatches or using their data in clinical decisions (for example, seeing a month of Apple Watch BP alerts and home readings to decide if a patient’s new medication is working). “By incorporating real-world data into clinic visits, clinicians can have a more holistic understanding of a patient’s cardiovascular risk,” Dr. Bhatt observed, emphasizing that tools like this create “patient agency” and earlier detection opportunities cardiovascularbusiness.com cardiovascularbusiness.com. Still, she and others maintain that patient and clinician interaction is key – the watch might prompt a visit, but it’s the confirmatory tests and conversations that lead to treatment decisions cardiovascularbusiness.com healthline.com.
For the average person, the message is empowerment with responsibility. If you have a compatible Apple Watch, the new feature could quietly be scanning for hypertension risk while you go about your life – that’s an impressive feat of technology and could be a lifesaver. If it alerts you, take it seriously: check your blood pressure properly and talk to your doctor. If it never alerts you, that’s good news but not an ironclad guarantee; still keep an eye on your health in general. Meanwhile, if you use a Samsung watch outside the U.S. or a device like Huawei’s, you have access to actual BP readings on the go – just remember to calibrate as required and treat the numbers as informative estimates, not gospel. And for those really needing to monitor blood pressure closely (say, hypertensive patients under treatment), no wearable should replace daily checks with an FDA-approved home monitor for now healthline.com.
In summary, Apple’s blood pressure notification and similar smartwatch features from competitors represent a bold step into one of healthcare’s most important fronts. They’re making the invisible visible – shining a light on a silent killer by using clever algorithms and ubiquitous sensors. This could lead to a future where routine blood pressure monitoring is as effortless as tracking your steps, integrated seamlessly into our lives. We are not fully there yet: the technology is still maturing, and medical validation is ongoing. But with each innovation and each regulatory green light, the gap between medical devices and consumer gadgets narrows. The prospect of a cuffless, accurate blood pressure monitor that you can wear 24/7 is on the horizon. Until then, these early solutions are valuable early warning systems. As one cardiologist put it, the real power lies in combining the strengths of wearables and healthcare professionals: “This tool empowers patients and clinicians to work together, putting prevention at the center of care” cardiovascularbusiness.com. The smartwatch on your wrist might not replace your doctor’s cuff, but it can certainly give you and your doctor a head start in keeping your blood pressure – and overall health – in check.
