MASSDEVICE ON CALL — Sotera Wireless this month touted FDA clearance for a new feature of its ViSi Mobile continuous non-invasive blood pressure system, now able to monitor patients without the use of a catheter or blood pressure cuff.
The novel new device has long been part of Sotera’s product portfolio, but wasn’t cleared alongside earlier ViSi Mobile systems.
"The ViSi Mobile System is the 1st wrist-worn monitor to measure all core patient vital signs: cNIBP, heart rate or pulse rate, electrocardiogram (ECG), blood oxygenation level, respiration rate and skin temperature, with the accuracy of systems used in hospital intensive care units," according to a company statement. "Wireless technology transmits vital sign data, enabling clinicians to monitor measurements on remote viewing or notification devices. The system incorporates safety features, such as an advanced alarm management system that notifies clinicians of unfavorable changes in a patient’s condition, enabling early intervention if needed."
Sotera last year won FDA clearance for the initial generation and then a 2nd generation of its ViSi Mobile systems, launching commercially immediately.
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