Healthcare Industry News:  FDA 

Devices Monitoring FDA

 News Release - July 1, 2022

Livemetric Receives FDA Clearance for its Watch-Like Wearable Blood Pressure Monitoring Technology, a Long-Awaited Revolution in Cuff-Free Hypertension Monitoring

LiveMetric is launching LiveOne, an FDA-cleared wearable technology for health systems, health insurers, and self-insured employers to improve the care and treatment of people with hypertension and cardiovascular disease

DENVER and LUXEMBOURG, June 30, 2022 -- (Healthcare Sales & Marketing Network) -- LiveMetric, a leader in medical wearable technology, today announced the launch of LiveOne, the world's first 510(k) U.S. Food and Drug Administration (FDA) cleared nano-sensor technology for monitoring blood pressure every 10 seconds. LiveOne is a wrist-worn, cuff-free solution that provides real time measurements to improve the care and treatment of people with hypertension and 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.

"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, MD, Professor of Medicine at the University of Chicago, and Director of AHA Comprehensive Hypertension Center. "Its innovative design provides an affordable, daily monitor which empowers users to know their blood pressure from 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."

"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, VP, 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 radical 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.

Please visit livemetric.com for more information.

About LiveOne

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 highly convenient and easy-to-use. The LiveMetric Platform provides decision support data to both payers and caregivers to improve patient outcomes and cost efficiency.

About LiveMetric

LiveMetric is an innovative leader in the care and treatment of hypertension and cardiovascular disease. Through the unique coupling of MEMS nano sensors with AI algorithms the LiveOne device provides BP measurements with unprecedented accuracy. The LiveMetric platform allows for third parties to manage a patient's condition through an easy integration to the LiveMetric platform. For more information, please visit livemetric.com


Source: LiveMetric

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