West Health Blog: Sotera Wireless Gets 510(k) Clearance

Last week, we were really excited to see a portfolio company of the West Health Investment Fund hit a pivotal milestone in their mission when Sotera Wireless announced their Wireless ViSi Mobile Patient Monitoring System received a 510(k) clearance from the FDA to transmit patient’s vital signs.

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Sotera Wireless gets FDA clearance for ViSi Mobile System, to begin sales

At long last, Sotera Wireless announced today it has received FDA 510k clearance for the entire ViSi Mobile System and will immediately commence sales to hospitals nationwide.

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ViSi Mobile System for Real Time Wireless In-Hospital Vital Signs Monitoring (video)

The FDA has cleared Sotera Wireless‘ ViSi Mobile System that’s designed for monitoring of vital signs of ambulatory patients in non-ICU clinical settings.   The wrist-worn device works with a number of sensors that measure blood pressure, heart rate / pulse rate, SpO2, respiratory rate, skin temperature, as well as 3-lead or 5-lead ECG.   All the data is sent over a standard (802.11) in-hospital wireless network to a central server for simultaneous real-time monitoring of all the patients on the floor using a computer or a tablet PC. The company promises the next version of the device will provide continuous non-invasive blood pressure monitoring as well as the patient’s posture and activity levels.

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Sotera Wireless receives FDA 510(k) clearance for ViSi Mobile System

Sotera Wireless, Inc. announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its full ViSi Mobile® System and is commencing sales to hospitals nationwide. The ViSi Mobile System, as approved, uses WiFi (802.11) wireless technology for transmission of patients’ vital signs, keeping hospital clinicians connected to their patients, whether patients are in bed or up and moving around. Earlier this year, Sotera announced 510(k) clearance for its first generation ViSi Mobile Monitor, which encompasses the stand-alone device portion of the system that for the first time provides continuous monitoring of all the core vital signs on a patient worn platform.

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FDA Approves Sotera Wireless Technology for Monitoring Vital Signs

It took a little longer than expected, but FDA regulators have cleared the mobile technology that San Diego’s Sotera Wireless has developed for monitoring hospital patients’ vital signs.

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