FDA Clears LiveMetric's Wearable Blood Pressure Monitoring Tech (2024)

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Wrist-worn device can monitor blood pressure over an entire week.

FDA Clears LiveMetric's Wearable Blood Pressure Monitoring Tech (1)

LiveOne, a wrist-worn, wearable blood pressure monitor. Image courtesy of LiveMetric.

Michael Barbella, Managing Editor08.17.22

LiveMetrichas received U.S. Food and Drug Administration 510(k) clearance for andlaunched LiveOne, a nano-sensor technology for monitoring blood pressure every 10 seconds.

“LiveMetric’s wrist-worn, wearable blood pressure monitor is an amazing solution to the inconvenience of the current BP cuff and Holter monitor,” said George Bakris, M.D., professor of Medicine at the University of Chicago, and director of AHA Comprehensive Hypertension Center. “Its design provides an affordable, daily monitor which empowers users to know their blood pressurefrom anywhere and at any time. The band makes it possible to evaluate not only a static 24-hr ABPM, but also to monitor BP over an entire week. It could also aid in our continuous research to improve diagnosis of secondary causes of hypertension that have variable BP increases.”

LiveOne is a wrist-worn, cuff-free solution that provides real time measurements to improve the care and treatment of people with hypertensionand cardiovascular diseases.The non-invasive device requires no external calibration and continuously extracts the pressure waveform out of the radial artery. The LiveOne monitoring service will be available through health systems, health insurers, and self-insured employers for people with high blood pressure and cardiovascular disease.

“The LiveOne device is intended to combat the worldwide epidemic of hypertension by offering patients and providers meaningful, deeply personalized health information so action can be taken in real-time,” said Kelly Benning, vice president at LiveMetric. “With the same ease as wearing a watch, the LiveOne device will change how hypertension and cardiovascular disease are managed and treated by offering people a thorough understanding of how their lifestyle, behavior, and medication impact their blood pressure. We are focused on bringing this to millions of users across the channels of our customer-base.”

A change to more than a century of monitoring blood pressure using cuffs, LiveMetric provides an urgently needed monitoring system to better evaluate and monitor people from anywhere and at any time. The LiveOne band, which can be used both day and night, provides an extensive volume of data points which enables clinicians and caregivers to easily evaluate trends and the likelihood of major events.

The LiveOne wearable is the world’s first MEMS nano-sensor-based, CE and FDA-cleared device with medical accuracy highly correlated to the arterial line. LiveOne is predicated on a unique technological approach, applying an array of high-frequency nanosensors that senses and processes actual pressure, and uses proprietary machine-learning to extract blood pressure values from the shape of the pulse waveform. Unlike the traditional cuff, it is calibration-free, making it convenient and easy to use. The LiveMetric Platform provides decision support data to both payers and caregivers to improve patient outcomes and cost efficiency.

LiveMetric develops hypertension and cardiovascular disease treatments.

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    FDA Clears LiveMetric's Wearable Blood Pressure Monitoring Tech (2024)

    FAQs

    What is the FDA approved wearable blood pressure monitor? ›

    Nanowear has secured the US Food and Drug Administration (FDA) 510(k) clearance for SimpleSense-BP, an artificial intelligence (AI)-enabled continuous blood pressure monitoring and hypertension diagnostic management platform.

    Is OMRON watch FDA approved? ›

    This noninvasive oscillometric BP monitor is the world's first FDA-approved fitness watch to provide accurate and automatic BP monitoring.

    How much does LiveMetric cost? ›

    The efficacy of a medicine can be seen quickly with LiveMetric, and care planning/treatment changes can be achieved via telehealth to improve outcomes. Designed to address a global epidemic at the low cost of $250 + freemium or $3/$9 monthly subscription fees.

    Do any wearable devices track blood pressure? ›

    The best blood pressure watch is the Omron HeartGuide. In 30 seconds, you can take a clinically accurate blood pressure reading with just the watch. You can also track trends in your blood pressure over time and better understand your readings through the app.

    What device is FDA approved for high blood pressure? ›

    The FDA approved a radiofrequency renal denervation device for treatment of hypertension. "We appreciate the robust conversation that occurred prior to the vote," Jason Weidman, senior vice president and president of the coronary and renal denervation business at Medtronic, said in a press release.

    Can an Apple Watch detect blood pressure? ›

    “At this time, the Apple Watch isn't equipped to measure your blood pressure alone,” says Dr. Bronstein. “ [It] requires pairing with a [separate blood pressure measuring] device to measure and record your blood pressure.”

    Is OMRON a Chinese company? ›

    Omron Corporation (オムロン株式会社, Omuron Kabushiki-gaisha), styled as OMRON, is a Japanese electronics company based in Kyoto, Japan. Omron was established by Kazuma Tateisi (立石一真) in 1933 (as the Tateisi Electric Manufacturing Company) and incorporated in 1948.

    How accurate is OMRON BP watch? ›

    All OMRON blood pressure monitors are clinically proven accurate. They are clinically validated to be within the following: Blood pressure: within +/- 3 mgHg or 2 percent. Pulse: within +/- 5 percent of reading.

    What smartwatch do cardiologists recommend? ›

    Top 3 features of best smartwatches for heart patients for you
    Best smartwatch for heart patientsDisplay
    Apple Watch SE (2nd Gen) [GPS 40 mm]1.78 inches
    Fastrack Reflex Play Smart Watch1.3 inch AMOLED
    Apple Watch Series 91.7 inches
    beatXP Vega1.43 inch Round AMOLED
    6 more rows
    Jan 4, 2024

    Can smart watch really measure blood pressure? ›

    Yes, several smartwatches measure blood pressure, including the Omron HeartGuide and the Samsung Galaxy Watch 5. Their readings are unlikely to be as accurate as those from the blood pressure monitors doctors use, but they can help people keep track of their blood pressure in between medical appointments.

    Do any of the blood pressure apps actually take your blood pressure? ›

    In general, the study found the apps to be helpful for tracking blood pressure, but they cannot actually measure blood pressure, they just extrapolate what your blood pressure may be from other data like finger pulse. This is not guaranteed to be accurate.

    Is there a blood pressure monitor to wear? ›

    If you have high blood pressure, home monitors can be a great way to track your levels and keep them under control. Most of the devices currently available are versions of what your healthcare provider uses: stand-alone devices with cuffs that you apply to your wrist or upper arm.

    Which wearable is FDA approved for ECG? ›

    Samsung Galaxy Watch Active 2-FDA Approved ECG Smartwatch

    Along with the Samsung Galaxy Watch3, the ECG app will be released on the Galaxy Watch Active2. This smartwatch's ECG tracking feature is FDA-approved for staff to track heart rate.

    Is Withings blood pressure monitor FDA approved? ›

    BPM Connect has received FDA clearance and CE marking for medical devices.

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