TL;DR
Which wearable blood pressure monitors are FDA-cleared?
Only a handful of wearables are cleared in the US to measure blood pressure, and they work in one of two ways. Some watches have a small cuff inside the strap that inflates for each reading, which is the same method a home arm monitor uses. The Omron HeartGuide is the best known of these. The FDA cleared it in 2018, although Omron no longer lists it on its US website, and our smart watch blood pressure guide compares it with the other cuff-based watches.
The others are cuffless. The Hilo band, which was sold as Aktiia before it was renamed, is a wristband that reads your pulse with light sensors and works out your blood pressure from it, and you set it up with an arm cuff that comes in the box. In July 2025 the FDA cleared Aktiia's G0 system, the technology behind the band, for spot-check readings at home in adults aged 22 to 59, with a fresh check against the cuff every 24 hours. Hilo says that clearance doesn't cover Hilo Core, the version it now sells in the US, which is a general wellness product. Hilo Core is designed to be worn day and night, and you set it up against the cuff again every 30 days.
The Apple Watch sits apart from both. The FDA cleared its hypertension notification in September 2025. On the Series 9 and later and the Ultra 2 and later, it looks at data from the watch's optical heart sensor over 30-day periods and alerts you when it sees a pattern that suggests high blood pressure. It never shows you a number, and it's meant for adults aged 22 or over who aren't pregnant and haven't been diagnosed with high blood pressure. Apple says not everyone with high blood pressure will get a notification, and that the feature may not yet be available on the Series 12 or Ultra 4 in some regions while their own clearances are in process.
Samsung Galaxy Watches do show a reading once you have set them up against an arm cuff, which you buy separately and use again every 28 days. Samsung began rolling the feature out to US users in March 2026 as a wellness tool, and it isn't FDA-cleared. See our Apple Watch blood pressure and Samsung Galaxy Watch blood pressure guides for the detail.
| Device | How it measures | Shows a number? | US status (checked October 2026) |
|---|---|---|---|
| Omron HeartGuide | Small cuff in the strap | Yes | FDA-cleared in 2018. Omron no longer lists it on its US website. |
| Hilo band (formerly Aktiia) | Light sensors, set up with an arm cuff | Yes | Its Aktiia G0 technology was FDA-cleared in 2025 for spot checks. Hilo Core, the version sold in the US, is a wellness product and isn't FDA-cleared. |
| Apple Watch | Light sensors, looks for a pattern over 30 days | No, it sends a notification | Hypertension notification FDA-cleared in 2025 |
| Samsung Galaxy Watch | Light sensors, set up with an arm cuff | Yes | Rolling out in the US since March 2026 as a wellness feature, not FDA-cleared |
Why Most Wearables Fall Short
Blood pressure measurement has traditionally required an inflatable cuff that temporarily stops blood flow in your arm. This oscillometric method is what most automatic home monitors use: the cuff picks up the pulses in your artery as pressure changes in the cuff itself, and the monitor works out your blood pressure from them.
Wearable devices, on the other hand, typically use optical sensors (photoplethysmography or PPG) to estimate blood pressure by analyzing how light reflects off your blood vessels. While convenient, this indirect method has significant limitations.
Types of Wearable BP Monitors
1. Cuffless Wearables (Rings, Bands, Standard Smartwatches)
These devices use optical sensors to estimate blood pressure through pulse wave analysis. Examples include certain fitness bands and smart rings that claim BP monitoring capabilities. See our deep dives on the RingConn smart ring blood pressure feature and whether the Oura Ring measures blood pressure.
Pros:
- Some take readings in the background through the day
- No cuff discomfort
- Can take readings while you sleep
Cons:
- Less accurate than cuff-based devices
- Require frequent calibration with a cuff monitor
- Not suitable for diagnosis or medication adjustments
- Accuracy affected by movement, skin tone, and temperature
2. Hybrid Smartwatches (Mini Inflatable Cuffs)
Cuff-based smartwatches have a small pump and cuff in the strap, so each reading works the way a wrist blood pressure monitor does. We compare these watches model by model in our guide to the best smart watch blood pressure monitors.
Are cuffless blood pressure monitors accurate?
They aren't yet reliable enough to act on. In a scientific statement published in December 2025, the American Heart Association said the cuffless devices on the market haven't been adequately checked for accuracy, even though several have FDA clearance. It also noted that studies have found them poor at tracking blood pressure changes during exercise, during sleep and after blood pressure medication. The 2025 AHA/ACC high blood pressure guideline recommends against using them to diagnose or manage high blood pressure.
Cuffless monitors work out pressure from your pulse, so many of them need setting up against an arm cuff first and checking against it again as often as the maker says. Movement, a loose strap and cold hands can all throw a reading off. If you're choosing one, ask whether the maker has published validation results, and check any reading that worries you with a validated arm cuff.
Is there a blood pressure monitor you can wear all the time?
Yes. A cuffless band such as Hilo Core is designed to be worn day and night, including while you sleep, and it takes readings when you're still. A cuff-based watch takes a reading whenever you ask it to. The accuracy limits above still apply to those readings. When a doctor needs a full day of readings to make a diagnosis, they usually give you a 24-hour ambulatory monitor, which is an arm cuff you wear for a day and a night that inflates by itself at set times.
When Wearables Make Sense
Wearable BP monitors have their uses, because they serve a different purpose from clinical-grade devices. Consider using a wearable if:
- You're curious about patterns: Readings through the day and night can give you questions to take to your doctor, as long as you treat the numbers as rough and confirm them with a cuff.
- You're already monitoring with a cuff: Use wearables to fill in the gaps between your morning and evening cuff measurements.
- You have "white coat syndrome": A wearable gives you readings away from the clinic to talk through with your doctor, who can confirm white coat hypertension with a 24-hour monitor.
- You're motivated by data: More data points can encourage healthy habits, even if each reading isn't clinical-grade.
When to Stick with a Cuff Monitor
A validated upper-arm cuff monitor remains essential if:
- Your doctor is adjusting your blood pressure medication
- You're newly diagnosed with hypertension
- You need readings for a specific health condition
- You're tracking blood pressure during pregnancy
- You want readings from a validated device for peace of mind
Important
Tips for Using Any BP Monitor
- Calibrate regularly: Even cuff monitors should be checked against a clinical device annually.
- Measure at the same time daily: Blood pressure naturally fluctuates; consistency helps you spot true trends.
- Rest before measuring: Sit quietly for 5 minutes before taking a reading.
- Position correctly: Keep the monitor at heart level, whether it's on your arm or wrist.
- Track your data: Use an app like Cardilog to log readings, visualize trends, and share reports with your doctor.
The Bottom Line
Wearable blood pressure monitors are improving rapidly, and they have a place in your health toolkit, especially for convenience. But for now, a validated upper arm cuff remains the gold standard for accurate, actionable blood pressure data.
The best approach is to use both. Let a wearable add convenience and extra readings, and use a validated cuff monitor for the readings that really matter.