LiveOne Smartwatch Gets FDA Clearance for Blood Pressure Monitoring

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LiveOne Smartwatch Gets FDA Clearance for Blood Pressure Monitoring

Overview

LiveMetric released a smartwatch device that can monitor blood pressure. What makes this device unique is the absence of a cuff. 

The United States Food and Drug Administration (FDA) granted this device a 510(k) clearance. This was the result of proving that the LiveOne blood pressure monitoring device is as reliable as Tensys Medical’s TL300. The latter is a device that measures blood pressure continuously. Unlike TL300, however, LiveOne is smaller and offers more portability.

Officials from LiveMetric expressed their appreciation of this decision and revealed their plans to make LiveOne commercially available for the public. The main target of this device is people with high blood pressure and heart disease.

This article will cover the importance of giving clearance to LiveMetric’s new device and how it could influence high blood pressure.

Factors that influence blood pressure monitoring

Monitoring blood pressure faces several challenges, mainly revolving around patient compliance. This is especially true in cases where blood pressure needs to be continuously monitored. Wearing a cuff for 24 hours can be quite uncomfortable, leading patients to remove it.

Another major factor that impacts blood pressure monitoring is white coat syndrome. This is a well-documented condition where people develop a temporary elevation in their blood pressure while around doctors or in the clinic. As a result, the obtained numbers are inaccurate, precipitating unnecessary tests and treatments. 

This is why doctors rarely commence treatment unless ambulatory blood pressure monitoring (ABPM) confirms the diagnosis. 

All of this led to a surge in ambulatory home blood-pressure monitoring (ABPM) devices. Unfortunately, many patients do not comply with their doctor’s instructions due to the inconvenience of the cuff that comes with these devices.

How is LiveOne going to solve these issues

LiveOne uses a complex algorithm to analyze blood flow through the radial artery. After making relevant calculations, the device will show three parameters:

  • Diastolic blood pressure
  • Systolic blood pressure
  • Pulse rate

The 510(k) clearance granted by the FDA allows clinics to use LiveOne to assess blood pressure readings in people aged 27 and older.

Note that this clearance comes after publishing a study that included 34 patients. Comparing the blood pressure readings in these patients using LiveOne and intraarterial catheters showed similar results. The researchers of the study stated 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.”

When this device gets full approval by the FDA, it will help patients in a variety of ways. By providing 24h readings, doctors will be more certain of their diagnosis. Additionally, patients will be compliant as these devices do not have a cuff and thus don’t cause any inconvenience.

Finally, when patients become able to use these devices at home, the effects of the white coat syndrome will no longer be a contributing factor.

Takeaway message

LiveMetric’s new device can offer many solutions to patients with chronic blood hypertension and their physicians. The 501(k) clearance by the FDA is the first step toward the commercial use of this device.

Hopefully, this article managed to explain the potential impact of LiveOne on the field of high blood pressure.

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