Technology | Wearable Sensors | December 12, 2017

VitalConnect Secures Fifth FDA Clearance for Patient Monitoring Device

The VitalPatch wearable biosensor will include five-day wear duration in alignment with nation's average hospital stay

VitalConnect Secures Fifth FDA Clearance for Patient Monitoring Device

December 12, 2017 — 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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