Wearable Blood Pressure Monitors FDA Status

For millions of people managing hypertension, the idea of ditching the bulky, squeezing arm cuff for a sleek smartwatch is incredibly appealing. Technology companies have been racing to develop “cuff-less” blood pressure monitoring for years. However, the path to FDA clearance is difficult because medical accuracy is non-negotiable when heart health is on the line.

While dozens of cheap fitness trackers online claim to read your blood pressure, very few have passed the rigorous validation required by the U.S. Food and Drug Administration (FDA). Here is a detailed look at the current status of wearable blood pressure monitors and which devices are actually recognized by regulators.

The Only "True" FDA-Cleared Smartwatch: Omron HeartGuide

If you are looking for a consumer smartwatch that you can buy today with full FDA clearance as a medical device, the list is extremely short. In fact, it currently contains only one major standout: the Omron HeartGuide.

However, there is a technicality. The Omron HeartGuide is not truly “cuff-less.” It is an oscillating blood pressure monitor miniaturized into a wristwatch form factor.

  • How it works: The band of the watch actually inflates. It squeezes your wrist just like a traditional doctor’s cuff to take a measurement.
  • FDA Status: It received FDA 510(k) clearance in 2018.
  • Accuracy: Because it uses the traditional oscillometric method, it is highly accurate.
  • Drawbacks: It is bulky (about 14mm thick), requires daily charging if you measure often, and comes with a steep price tag usually around $499.

While this device proves accurate wrist-based monitoring is possible, it does not fulfill the dream of passive, sensor-based monitoring that does not squeeze you.

The Breakthrough: LiveMetric LiveOne

The most significant recent development in truly cuff-less technology comes from a company called LiveMetric. In June 2022, LiveMetric received FDA 510(k) clearance for its LiveOne storage and transmission band.

This is distinct from the Omron device because it does not inflate.

  • The Technology: Instead of using air pressure or standard optical light sensors (PPG) found in Fitbits, the LiveOne uses MEMS (micro-electromechanical systems) nano-sensors. These sensors press gently against the radial artery on the wrist to detect pressure waveforms.
  • Why it matters: This device can sample blood pressure as frequently as every 10 seconds. This provides a continuous stream of data rather than a single snapshot.
  • Availability: As of early 2024, this device is primarily targeted at health systems and remote patient monitoring programs rather than direct-to-consumer sales like an Apple Watch. However, its FDA clearance marks a massive shift in regulatory acceptance for cuff-less sensors.

Samsung Galaxy Watch: The "Almost" Solution

Owners of the Samsung Galaxy Watch 5, 6, and 7 might be confused. Samsung heavily advertises blood pressure monitoring features for these watches globally. However, if you are in the United States, you cannot access this feature natively.

  • The Method: Samsung uses Pulse Wave Analysis (PWA). It analyzes the light sensor data (PPG) to estimate blood pressure based on blood flow changes.
  • FDA Status: Not cleared in the U.S. While the feature is approved and active in South Korea, Europe, and 30+ other regions, the FDA has not yet cleared this specific software application for American users.
  • The Catch: Even where it is available, the Samsung watch is not fully independent. It requires “calibration” every 28 days using a traditional arm cuff. The watch essentially learns your baseline and tracks changes relative to that calibration. It cannot determine your blood pressure from scratch without that reference point.

The Contenders: Aktiia and Valencell

Two other companies are making significant strides toward FDA clearance for cuff-less devices that consumers actually want to wear.

Aktiia

Aktiia is a Swiss company that sells a lightweight bracelet in Europe. It has no screen and looks like a simple jewelry band. It automatically measures blood pressure 24⁄7 using optical sensors.

  • Status: Aktiia is currently conducting a pivotal clinical trial in the United States. They are collaborating with Brigham and Women’s Hospital to validate their data for the FDA.
  • Goal: They are aiming for full FDA clearance to sell directly to U.S. consumers. Until that clearance is granted, you cannot officially buy or import the device for medical use in the States.

Valencell

Valencell is known for making the heart rate sensors used in many popular wearables. They have pivoted to creating their own blood pressure device.

  • The Device: Unlike a watch, this is a fingertip clip device. You place it on your finger for a minute to get a cuff-less reading.
  • Status: Valencell announced at CES that they are seeking FDA clearance for over-the-counter use. This solution is intended to help people measure BP quickly without the hassle of wrapping a cuff around their arm.

Why the Apple Watch Is Missing

You might wonder why the Apple Watch, the most popular wearable in the world, does not have this feature yet.

Mark Gurman, a reliable tech reporter for Bloomberg, has indicated that Apple encountered engineering challenges during testing. While the Apple Watch Series 9 and Ultra 2 introduced advanced health features, they did not include blood pressure numbers.

Apple is reportedly focusing on hypertension detection rather than giving specific systolic/diastolic numbers. The goal is for the watch to alert you if your blood pressure is trending upward over time, prompting you to verify with a medical-grade cuff. There is no official timeline for when this feature will receive FDA clearance or release.

A Warning on "FDA Registered" vs. "FDA Cleared"

If you search Amazon for “blood pressure watch,” you will find dozens of brands you have never heard of selling watches for $40 or $50. Many display badges saying “FDA Registered.”

This is a marketing trap.

  • FDA Registered: This simply means the manufacturer has provided the FDA with their contact information and a list of devices they make. It does not mean the device has been tested or proven accurate.
  • FDA Cleared/Approved: This means the FDA has reviewed data submitted by the company proving the device is substantially equivalent to existing medical tools and is safe and effective.

Always look for “FDA Cleared” or specific 510(k) clearance numbers. Relying on a non-cleared $50 watch to manage a heart condition can be dangerous, as these devices often provide random or “estimated” numbers that do not reflect reality.

Frequently Asked Questions

Is there any watch that measures blood pressure without squeezing? Currently, the LiveMetric LiveOne is the main FDA-cleared device that is truly cuff-less (non-inflating), but it is largely for clinical use. The Aktiia bracelet performs this function in Europe but is still awaiting U.S. FDA clearance.

Does the Apple Watch measure blood pressure? No. As of 2024, no Apple Watch model measures blood pressure. Third-party apps may claim to do so, but they generally require an external cuff or provide unverified estimates.

Are wrist blood pressure monitors accurate? Generally, upper-arm cuffs are considered the gold standard. Wrist monitors (like the Omron HeartGuide) can be accurate, but they are highly sensitive to body position. If your wrist is not held exactly at heart level during the reading, the numbers can be significantly skewed.

When will Samsung enable blood pressure in the US? Samsung has not provided a public date. It depends entirely on when the FDA is satisfied that the Galaxy Watch’s sensor-based algorithm is accurate enough to operate without misleading users. The requirement for monthly calibration with a real cuff remains a hurdle for “cuff-less” classification.