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Home » FDA clears Covidien’s latest Nellcor continuous respiratory monitor

FDA clears Covidien’s latest Nellcor continuous respiratory monitor

July 30, 2012 By MassDevice staff

Covidien logo

Medical device maker Covidien (NYSE:COV) touted FDA clearance for the latest in its line of Nellcor patient monitors, the Bedside SpO2.

The device continuously monitors SpO2 and pulse rate for adult, pediatric and neonatal patients, providing access to comprehensive respiratory trends and subtle variations.

"Healthcare professionals on the general care floor, and in other lower-acuity areas of the hospital, need critical patient information at their fingertips so they can respond quickly to health threats," Covidien respiratory & monitoring solutions president Robert White said in prepared remarks. "By giving them ready access to a patient’s respiratory history, the system allows them to focus on delivering efficient, high-quality care, not gathering and managing data."

Earlier this year the Mansfield, Mass.-based medical device company won FDA clearance for an earlier generation of the Nellcor respiration system with an adult respiratory sensor. Covidien won CE Mark approval to launch the device in the European Union in December 2011.

The new device features enhanced digital signal processing for more accurate and precise Sp02 readings during conditions that make it difficult to track, such as during low perfusion, according to a press release.

The Nellcor system also has SatSeconds alarm management technology that differentiates between serious and minor events and cuts down on the insignificant alarms.

Covidien has since 2009 partnered with fellow med-tech giant Philips (NYSE:PHG) to launch the Nellcor systems alongside the Philips IntelliVue patient monitoring platform.

Filed Under: 510(k), Food & Drug Administration (FDA), News Well, Respiratory Tagged With: Covidien

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