Sotera Wireless Reports FDA Clearance of ViSi Mobile System

Sotera Wireless, Inc. announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the ViSi Mobile™ System, a new continuous vital signs monitoring system for use in hospitals. The clearance represents a major milestone in Sotera’s effort to develop a comprehensive wireless patient monitoring system, particularly for ambulatory hospital patients.

“Continuous vital signs monitoring is crucial to detecting early deterioration in a patient’s condition and facilitating early intervention or rapid response,” said Tom Watlington, Sotera’s chief executive officer. “The ViSi Mobile System will stretch the boundaries of patient monitoring by enabling clinicians to receive this information without limiting a patient’s freedom to move about the hospital.”

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 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.

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 electrocardiography (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 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 electronic medical record (EMR) system. Sotera also expects to add novel sensing technologies to the system, including its patented cuffless non-invasive blood pressure (cNIBP).

About Sotera Wireless
Sotera Wireless, Inc. is a San Diego, California based medical device company dedicated to the development, marketing and sale of a new generation of comprehensive vital signs monitoring. Sotera’s mission is to improve patient safety by empowering clinicians to detect early signs of deterioration in virtually any care setting and enable early intervention and rapid response, all without limiting the patient’s freedom of movement. More information on the company can be obtained at www.soterawireless.com or by sending an email to info@soterawireless.com.