Sotera Wireless ViSi Mobile Patient Monitoring System Receives FDA Approval

Sotera Wireless declared that its full ViSi Mobile System has achieved 510(k) clearance from the U.S. Food and Drug Administration (FDA) and has started providing the system to nationwide hospitals.

The ViSi Mobile System employs WiFi (802.11) wireless technology for conveying the vital signs detected in patients. This system enables hospital clinicians to constantly remain connected to their patients.

During early 2012, Sotera reported 510(k) clearance for its G1 ViSi Mobile Monitor comprised of stand-alone device portion of the system. On a patient worn platform, this versatile device was able to seamlessly monitor the entire core vital signs, for the first time.

Various studies conducted over the years have demonstrated that patients in any hospital setting may be affected with preventable adverse events that may lead to extended hospitalization, injury or even death.

At present, continuous monitoring systems that allow detection of emerging problems are generally deployed in intensive care units (ICU) and other high-acuity areas of hospitals. In lower acuity areas where 60% to 70% of hospitalized patients are accommodated, collection of vital signs takes place using spot checks performed at an interval of 4-6 h.

The ViSi Mobile System is compactly configured for portability. It features non-invasive sensors that ensure convenience. It is ideal for effective deployment in ambulatory, and non-ICU clinical settings. The system can be used for precise capturing and wireless transmission of all core vital signs such as 3-lead or 5-lead ECG, SpO2, Blood Pressure, Heart Rate / Pulse Rate, Skin Temperature, and Respiration Rate.

Innovative sensing technologies such as Sotera's patented continuous non-invasive blood pressure (cNIBP) and patient posture/activity will be built within the upcoming versions of the ViSi Mobile System that are now in final stages of testing.

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