Cuff-Free BP Wearable Gets CE and FDA Clearance [video]

Luxembourg-based LiveMetric recently added FDA clearance to the existing CE clearance for the company’s LiveOne wrist-worn cuff-less blood pressure monitor. Cuffless BP monitoring is one of the holiest grails of wearable digital health technology development.

LiveMetric’s ground-breaking device employs an array of microelectromechanical systems (MEMS) high-frequency nanosensors to sense pressure from the radial artery in the wearer’s wrist. A proprietary machine-learning algorithm derives blood pressure values from the pulse frequency waveform. Unlike some other cuff-less BP technologies, the LiveOne does not require calibration with a conventional cuff. LiveOne measures blood pressure every 10 seconds.

Researchers who published a multicenter prospective cohort pilot study clinical trial report in the American Journal of Hypertension earlier this year concluded that “the LiveOne device provides continuous, noninvasive BP measurements that are accurate in comparison to A-line measurements.”

According to George Bakris, MD, Professor of Medicine at the University of Chicago, and Director of AHA Comprehensive Hypertension Center, “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 sends extracted blood pressure readings to the wearer and to caregivers, although we don’t have information on how the data is transmitted or presented. Caregivers can use the Live Metric Platform to monitor patients with hypertension and cardiovascular disease. Health providers and insurers will provide patients with the LiveOne wearable with the LiveMetric Platform monitoring service. At this time there is no mention of plans to sell the LiveOne directly to individuals.

FDA and CE clearance for sale in the U.S. and Europe, respectively, are a very big deal and our hopes are high for the significant potential health and wellness benefits of a clinical-grade cuff-less wearable.