FDA clears Livemetric blood pressure wearable

  • July 6, 2022
  • Steve Rogerson

Luxembourg firm Livemetric has received FDA clearance for its watch-like wearable blood pressure monitoring technology.

Called LiveOne, it is said to be the world’s first 510(k) US FDA cleared nano-sensor technology for monitoring blood pressure every ten seconds.

LiveOne is a wrist-worn, cuff-free device 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, professor of medicine at the University of Chicago. “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 24hr 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.”

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

“The LiveOne device is intended to combat the worldwide epidemic of hypertension by offering patients and providers meaningful, deeply personalised 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, behaviour and medication impact their blood pressure. We are focused on bringing this to millions of users across the channels of our customer-base.”

The LiveOne wearable is a MEMS nano-sensor-based, CE and FDA-cleared device with medical accuracy correlated to the arterial line. It applies an array of high-frequency nano sensors 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 payers and caregivers to improve patient outcomes and cost efficiency.