21 May 2013 - Healthcare company Covidien (NYSE:COV) reported on Monday the receipt of approval from the US Food and Drug Administration (FDA) 510(k) for its Nellcor pulse oximetry portfolio, which is used to measure arterial oxygen saturation.

This makes Covidien the first company to receive FDA clearance for a motion-tolerant bedside pulse oximetre portfolio that is also compliant with ISO 80601-2-61 (International Organization for Standardization standards for pulse oximetry).

According to the company, the devices covered by the action include Nellcor Bedside SpO2 Patient Monitoring System, Nellcor Bedside Respiratory Patient Monitoring System and NellcorN-600x Pulse Oximetry Monitoring System.

The company said that pulse oximetress provide an early warning of dangerous respiratory complications, enabling clinicians to detect and address life-threatening events sooner. Nellcor devices rely on cardiac-based signals to provide a more accurate reading that is closely tied to the patient's physiology. It ensures patient safety because patient movement can thwart accurate readings and delay diagnosis of serious respiratory compromise.