Sotera Wireless has announced it has received FDA clearance for a new vital signs monitoring system, according to a news release.
The ViSi Mobile system is described as a continuous vital signs monitoring system for use in hospitals. The FDA clearance applies to the first generation of the system capable of measuring and displaying all core vital signs. The wrist-worn device is intended 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.
Sotera says it is a milestone in the company'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 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 is headquartered in San Diego, Calif.
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