- A smartwatch-like blood monitoring device made by LiveMetric it’s armless has been granted 510(k) clearance by the Food and Drug Administration.
- LiveMetric has obtained permission after showing its LiveOne device is roughly equivalent to Tensys Medical’s TL300, a continuous bedside blood pressure monitor used in healthcare facilities. The LiveOne device is a smaller, more portable version of the technology.
- With the approval, the company is preparing to make the device available to people with high blood pressure and cardiovascular disease through health systems, insurers and self-insured employers.
Overview of the dive:
Efforts to monitor high blood pressure, a major risk factor for cardiovascular disease, face significant data collection challenges, including the discomfort of wearing blood pressure cuffs. white coat syndromewhere people with hypertension may see their blood pressure rise from the stress of being in a clinic.
Ambulatory home blood pressure (ABPM) monitors that can provide a more accurate picture of a patient’s condition have a cuff that can confuse wearers and only take intermittent readings.
The LiveOne device uses algorithms to analyze radial blood pressure and display diastolic, systolic and pulse rate. 510(k) clearance supports the use of the LiveOne to measure the blood pressure of individuals 27 years of age and older in a clinical setting.
LiveMetric’s 510(k) clearance comes months after the publication data from a study of the device in 34 patients. It compares favorably to arterial catheters inserted to monitor blood pressure, leading the researchers to conclude that “the portability and discreet nature of this device and the ability to provide continuous blood pressure measurements may offer advantages over compared to currently available blood pressure monitors”.