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Sotera Wireless obtains FDA approval for cNIBP technology

Sotera Wireless, a medical device company, has obtained an approval from the US Food and Drug Administration (FDA) for its continuous non-invasive blood pressure (cNIBP) technology, a new feature of the ViSi Mobile wireless patient monitoring system.

Sotera Wireless’ cNIBP technology will help physicians in monitoring all patient vital signs, including beat-to-beat blood pressure.

The cNIBP technology avoids the use of a catheter or blood pressure cuff and when compared to invasive arterial line procedures, this technology demonstrated a bias of less than 5 mmHg.

Using the cNIBP measurements, physicians can better manage the patients with hypertension.

Sotera Wireless CEO Tom Watlington noted blood pressure is one of the most important vital signs and yet it is considerably undervalued, largely because most clinicians are limited to periodic cuff-based measurements.

"By providing data collected around the clock without disrupting a patient’s sleep, we believe the ViSi Mobile System with cNIBP will help improve diagnosis and management of hypertension, saving lives and dollars," Watlington added.

The ViSi mobile system, a wrist-worn monitor, will measure all core patient vital signs: cNIBP, heart rate or pulse rate, electrocardiogram, blood oxygenation level, respiration rate and skin temperature, with the accuracy of systems used in hospital intensive care units.

The vital sign data then can be transmitted through its wireless technology, enabling physicians to monitor measurements on remote viewing or notification devices.

An advanced alarm management system has been included in the system to notify the physicians on unfavorable changes in a patient’s condition.