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Sotera ViSi Mobile System wins FDA 510(k) clearance

Sotera Wireless has won FDA 510(k) clearance for its full ViSi Mobile System and is commencing sales to hospitals nationwide.

The ViSi Mobile System, which consists of a small device and non-invasive sensors for freedom of movement, is designed for use in ambulatory, non-ICU clinical settings.

The ViSi Mobile System leverages WiFi (802.11) wireless technology for transmission of patients’ vital signs, keeping hospital clinicians connected to their patients.

Sotera chief executive officer Tom Watlington said patient safety is essential to hospitals and healthcare systems seeking to avoid the additional cost burden that can result from avoidable adverse events.

"Like a guardian angel, the ViSi Mobile System is on duty 24 hours monitoring vital signs with the aim of helping clinicians detect early signs of deterioration, allowing clinicians to intervene early to avoid unnecessary escalation of care, while also optimizing use of their time," Watlington added.

The system captures and wirelessly transmits all core vital signs (blood pressure, heart rate / pulse rate, 3-lead or 5-lead ECG, SpO2, Respiration Rate, Skin Temperature).