Sotera Wireless Receives FDA 510(k) Clearance for ViSi Mobile Vital Signs Monitoring System

Sotera Wireless has announced that it has received FDA 510(k) clearance for a new, mobile vital signs monitoring system, according to a news release.


The clearance applies to the first generation of the ViSi Mobile System, which is capable of measuring and displaying all core vital signs, according to Sotera Wireless. The wrist-worn device has been designed for use in ambulatory, non-ICU clinical settings and measures heart/pulse rate, 3- or 5-lead electrocardiography, oxygen saturation, blood pressure, respiration rate and skin temperature.


"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 CEO, in the release. "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."


Sotera Wireless says future generations of the system, currently under development and not yet cleared by 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 electronic medical record systems.


Sotera Wireless is based out of San Diego.


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