LiveMetric’s new cuffless, smartwatch-style blood-monitoring device has earned a 510(k) clearance from the FDA to take blood-pressure readings from those aged 27 and older. Following up on the approval, the company is pushing forward with plans to commercialize the device for health systems, insurers, and self-insured employers looking to equip high blood pressure and cardiovascular disease patients with what might be the most compact and portable version of this groundbreaking technology.
Aside from sheer convenience, ambulatory home blood-pressure monitoring (ABPM) devices such as these offer relief from the annoyance of wearing cuffs as well as what is known as “white coat syndrome,” where hypertension patients’ readings are thrown off by the potentially stressful nature of clinic visits.
LiveOne’s algorithms are capable of analyzing radial artery pressure to render displays for diastolic, systolic, and pulse rate. The FDA green light follows positive results from a 34-patient study of the device. It performed considerably better than arterial lines inserted for the same purpose, with researchers concluding that “the portability and unobtrusive nature of this device and the ability to provide continuous BP measurements may offer advantages over currently available BP monitors.”