New Hospital-Based Patient Monitoring System

Studies conducted worldwide have consistently shown that patients in any hospital setting may suffer preventable adverse events that could result in prolonged hospitalization, injury, or death. Currently, continuous monitoring systems, which can assist in identifying emerging problems, are typically used only in high-acuity areas of the hospital, like ICUs. In lower acuity areas, which host 60% to 70% of hospitalized patients, vital signs are typically collected via spot checks that are conducted at 4- to 6-hour intervals.

Sotera Wireless received 510(k) clearance from the U.S. FDA for the ViSi Mobile System, a new continuous vital signs monitoring system for use in hospitals. The 510(k) clearance applies to the first generation of the ViSi Mobile System capable of measuring and displaying all core vital signs. The small, wrist-worn device has been designed for use in ambulatory, non-ICU clinical settings and measures heart/pulse rate, 3- or 5-lead ECG, oxygen saturation (SpO2), blood pressure, respiration rate, and skin temperature.

Future generations of the system, now in development and not yet cleared by the U.S. FDA, are expected to include additional functionality, such as wireless transmission of data to computers or mobile devices for secondary viewing/notification and connectivity with a hospital’s EMR system. Sotera also expects to add novel sensing technologies to the system, including its patented cuffless non-invasive blood pressure (cNIBP).

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