International healthcare products major, Covidien plc ( COV ) has started labeling its Nellcor pulse oximeters to promote the usefulness of the product line for Critical Congenitial Heart Disease (CCHD) screening in infants. The systems can effectively detect and diagnose acute and potentially fatal breathing difficulties at an early stage, thereby allowing faster treatment and the elimination of respiratory complications.
Recently, the Food and Drug Administration (FDA) approved Covidien's Nellcor Bedside SpO2 Patient Monitoring System, Bedside Respiratory Patient Monitoring System and N-600x Pulse Oximetry Monitoring System for an expanded performance claim viz. motion tolerance. This feature is an added benefit to screen infants as they have a tendency to move during diagnosis.
The systems continuously monitor SpO2 as well as the pulse rate for adult, neonatal and pediatric patients. The FDA had already approved the product for use in infants. In 2012, the regulatory body had cleared the Nellcor Bedside SpO2 Patient Monitoring System and the Bedside Respiratory Patient Monitoring System for sale in the U.S.
The FDA approval underlines Covidien's commitment toward patient safety across general as well as critical areas of hospital care. The Nellcor pulse oximeters are the only FDA-approved devices that are compliant with ISO 80601-2-61 (International Organization for Standardization standards for pulse oximetry).
Additionally, the company will provide pulse oximetry training through its new Professional Affairs and Clinical Education Online Platform to support the safe use of motion-tolerant pulse oximeters.
According to the Centers for Disease Control and Prevention (CDC), about 7,200 babies in the U.S are diagnosed with CCHD every year. Although the disease is curable, about 100 to 200 infants are discharged without proper treatment and suffer serious disabilities and even fatality. Hence, Covidien has taken up the initiative to spread the awareness among hospitals to make CCHD screening mandatory for newborns.
The company currently carries a Zacks Rank #5 (Strong Sell) due to a dismal fiscal 2013 guidance provided by management. While we prefer to avoid Covidien until we see signs of improvement in the company's performance, other medical device stocks worth a look are Conceptus ( CPTS ), Neogen ( NEOG ) and Myriad Genetics ( MYGN ). All these stocks carry a Zacks Rank #2 (Buy).
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