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FDA Clears Bedside Respiratory Monitoring System

U.S. availability expected soon (Oct. 4)

Covidien, based in Boulder, Col., announced on October 4 that the FDA has given 510(k) clearance to the company’s Nellcor Bedside Respiratory Patient Monitoring system.

The new system provides continuous monitoring of blood oxygenation (SpO2) and pulse rate, along with trend data, to help clinicians detect and respond to dangerous respiratory events sooner. The system is upgradable onsite to accommodate new parameters and features, thereby reducing service disruptions and costs for hospitals.

The Nellcor system features a color touch-screen graphical user interface and provides a variety of wired and wireless connectivity options to meet the various needs in different hospital settings. It can connect to the Nellcor OxiNet III Remote Respiratory Monitoring system, enabling clinicians to monitor multiple patients from a central monitoring station on the general-care floor.

A SatSeconds alarm-management feature helps clinicians differentiate between serious and minor events, thereby reducing clinically insignificant desaturation alarms and alarm fatigue. The monitoring system also features a Saturation Pattern Detection alert for automated, real-time detection of patterns of desaturation that indicate repetitive reductions in airflow.

The new system will be available in the U.S. in the next few months.

For more information, visit the Covidien Web site.

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