VitalConnect Secures Fifth FDA Clearance for Wearable Biosensor

VitalConnect Inc., a developer of wearable biosensor technology for wireless monitoring in hospital and remote patient populations, announced its fifth 510(k) market clearance from the U.S. Food and Drug Administration. This clearance extends the wear duration for the company’s existing Class 2 wearable biosensor, 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 unprecedented insight into patient health and providing potential cost savings for hospitals. The VitalPatch biosensor is a single patient use and fully disposable device, providing convenience for caregivers and comfort for patients. The VitalPatch biosensor is also used beyond the hospital walls where continuous monitoring is needed, including post-discharge monitoring, remote patient monitoring, and in clinical trials.
 
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).
 
“The extended wear duration for our fully disposable VitalPatch biosensor supports our commitment toward improving patient care and enabling nurses and physicians to have real-time insight into their patients’ vitals and well-being,” said Dr. Nersi Nazari, CEO and founder, VitalConnect.