Medical device company Covidien (NYSE:COV) landed FDA 510(k) clearance and European CE Mark approval for the Nellcor bedside respiratory patient monitoring system, which will help clinicians detect and respond to dangerous respiratory events sooner, the company said.
The new Nellcor system can accommodate new parameters and features when monitoring blood oxygenation and pulse rate and it can reduce service disruptions and costs for hospitals, according to Covidien.
“We are pleased to announce clearance to market the Nellcor bedside respiratory patient monitoring system in the U.S. and the EEA,” said Robert White, the president of the company. “With this addition, we now offer an updated portfolio of industry-leading bedside monitoring solutions that meet unique care needs in both high- and low-acuity settings, thus enhancing patient safety in hospitals throughout the world.”
The new color touch-screen system provides wired and wireless connectivity options and helps clinicians monitor multiple patients from a central monitoring station when connecting to the Nellcor OxiNet III remote respiratory monitoring system.
The product will be available in the U.S. and countries that recognize the CE Mark in the next few months, according to the press release.
Covidien last month won FDA clearance for LigaSure surgical sealer/divider for ear, nose and throat procedures
and in August landed an FDA nod for its battery-powered iDrive Ultra surgical stapler.
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