VitalConnect Secures Fifth FDA Clearance for Patient Monitoring Device
VitalConnect Secures Fifth FDA Clearance for Patient Monitoring Device

VitalConnect Inc. announced its fifth 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for the company’s existing Class 2 wearable biosensor, the VitalPatch. This clearance extends the wear duration for the VitalPatch by 25 percent from 96 hours (four days) to 120 hours (five days).

The national average for a patient length of stay in the hospital is 4.5 days, according to the Agency for Healthcare Research and Quality within the U.S. Department of Health and Human Services. With a wear duration that covers the average hospital stay, the VitalPatch biosensor is ideally suited for hospital patient monitoring; offering insight into patient health and providing potential cost savings for hospitals. The biosensor is a single-patient-use and fully disposable device, providing convenience for caregivers and comfort for patients. The device is also used beyond the hospital walls where continuous monitoring is needed, including post-discharge monitoring, remote patient monitoring and in clinical trials.

VitalConnect said the clinical-grade VitalPatch is the industry's smallest and lightest wearable biosensor that measures eight different biometric measurements continuously and in real-time. The eight patient measurements include: single-lead ECG (electrocardiography), heart rate, heart rate variability, respiratory rate, skin temperature, body posture, fall detection and activity (steps).

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