Sotera Wireless receives FDA 510(k) clearance for ViSi Mobile System

Sotera Wireless, Inc. announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its full ViSi Mobile® System and is commencing sales to hospitals nationwide. The ViSi Mobile System, as approved, uses WiFi (802.11) wireless technology for transmission of patients' vital signs, keeping hospital clinicians connected to their patients, whether patients are in bed or up and moving around. Earlier this year, Sotera announced 510(k) clearance for its first generation ViSi Mobile Monitor, which encompasses the stand-alone device portion of the system that for the first time provides continuous monitoring of all the core vital signs on a patient worn platform.

"The way the majority of ambulatory patients in general care hospital settings around the world are monitored today is inadequate and may put patients at risk," said Beth Mancini Ph.D., R.N., professor, associate dean and chair for undergraduate nursing programs at the University of Texas at Arlington. "Wireless continuous monitoring of key vital signs holds the promise to substantially change this and allow early detection of patient deterioration and enable rapid response by constantly monitoring all vital signs."

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 hospitals, such as intensive care units (ICU). In lower acuity areas, which host 60 to 70 percent of hospitalized patients, vital signs are typically collected via spot checks that are conducted at four to six hour intervals.

"Patient safety is essential to hospitals and healthcare systems seeking to avoid the additional cost burden that can result from avoidable adverse events," said Tom Watlington, Sotera's chief executive officer. "Like a guardian angel, the ViSi Mobile System is on duty 24 hours monitoring vital signs with the aim of helping clinicians detect early signs of deterioration, allowing clinicians to intervene early to avoid unnecessary escalation of care, while also optimizing use of their time."

The ViSi Mobile System is designed for use in ambulatory, non-ICU clinical settings and consists of a small device, slightly larger than a sports watch, and comfortable non-invasive sensors allowing for freedom of movement. The system accurately captures and wirelessly transmits all core vital signs (Blood Pressure, Heart Rate / Pulse Rate, 3-lead or 5-lead ECG, SpO2, Respiration Rate, Skin Temperature). Future versions of the ViSi Mobile System, currently in final stages of testing, will also incorporate novel sensing technologies, including Sotera's patented continuous non-invasive blood pressure (cNIBP) as well as patient posture/activity.

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