International healthcare products major,
) 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
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
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
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
). All these stocks carry a Zacks Rank #2 (Buy).
COVIDIEN PLC (COV): Free Stock Analysis
CONCEPTUS INC (CPTS): Free Stock Analysis
MYRIAD GENETICS (MYGN): Free Stock Analysis
NEOGEN CORP (NEOG): Free Stock Analysis
To read this article on Zacks.com click here.