VitalConnect Inc has received its fifth 510(k) market clearance from the US FDA that extends the wear duration for the company’s existing Class 2 wearable patient monitoring biosensor, the VitalPatch. The clearance means the device can now be worn for up to 120 hours (five days).
The VitalPatch 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.
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.