Dive Brief:
- A smartwatch-like blood-monitoring device made by LiveMetric that’s cuff-free was granted 510(k) clearance by the Food and Drug Administration.
- LiveMetric secured the clearance after showing its LiveOne device is substantially equivalent to Tensys Medical’s TL300, a continuous blood-pressure monitor used at the bedside in healthcare facilities. The LiveOne device is a smaller, more portable spin on the technology.
- With the approval, the company is preparing to make the device available to people with high blood pressure and cardiovascular disease via health systems, insurers and self-insured employers.
Dive Insight:
Efforts to monitor high blood pressure, a major risk factor for cardiovascular disease, face significant data-gathering challenges from factors including the discomfort of wearing cuffs to white coat syndrome, where people with hypertension may see their blood pressure rise from the stress of being in a clinic.
Ambulatory home blood-pressure monitoring (ABPM) devices that may provide a more accurate picture of a patient’s condition have a cuff that can disturb wearers and only take intermittent readings.
The LiveOne device uses algorithms to analyze radial artery pressure and display diastolic, systolic and pulse rate. The 510(k) clearance supports the use of the LiveOne to take blood pressure readings from people aged 27 and older in clinic settings.
LiveMetric’s 510(k) clearance comes months after the publication of data from a study of the device in 34 patients. It compares favorably to the arterial lines inserted to monitor blood pressure, leading the researchers to conclude “the portability and unobtrusive nature of this device and the ability to provide continuous BP measurements may offer advantages over currently available BP monitors.”
