FDA Clears Wireless Device For Inpatient Vital Signs Monitoring

In short

California based company Sotera Wireless, Inc. has received FDA 510(k) clearance for its ViSi Mobile™ System, a new continuous vital signs monitoring system for use in hospitals. The product forms one component of  Sotera’s comprehensive wireless patient monitoring system, particularly targeted at ambulatory hospital patients.


Sotera Wireless Inc., is of the opinion that inpatient vital signs monitoring outside Intensive Care Units (ICUs) is a fertile business area in future healthcare provision in order to avoid patients suffering preventable adverse health events that could result in prolonged hospitalisation, injury or even death. Sotera’s mission is to improve patient safety by the detection of 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.

Currently, continuous monitoring systems, which can assist in identifying emerging problems, are typically used only in high-acuity areas of the hospital, like ICU. In lower acuity areas, which host 60 to 70 percent of hospitalised patients, vital signs are typically collected via spot checks that are conducted at four to six hour intervals.

The 510(k) clearance of Sotera’s Visi Mobile™ System applies to the first generation product, which is 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.

Company comments

“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.”

What’s next?

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).

ViSi Mobile™ is a trademark of Sotera Wireless, Inc.

SOURCE Sotera Wireless, Inc., PR Newswire