The US Food and Drug Administration (FDA) has granted 510(k) approval to Sotera Wireless' ViSi Mobile system.
The small, wrist-worn ViSi Mobile is a continuous vital signs monitoring system designed for use in ambulatory hospitals and non-ICU clinical settings.
The ViSi Mobile System measures heart/pulse rate, 3- or 5-lead electrocardiography (ECG), oxygen saturation (SpO2), blood pressure, respiration rate and skin temperature.
Sotera chief executive officer Tom Watlington said continuous vital signs monitoring is crucial to detect early deterioration in patient’s condition and facilitates early intervention.
"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," Watlington added.
Sotera said future generation systems 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.
The company expects to add sensing technologies to the system including its patented cuffless non-invasive blood pressure (cNIBP).