FDA Nod for COV's Advanced Nellcor - Analyst Blog
21 Mayo 2013 - 10:00AM
Zacks
International health care products
major, Covidien plc (COV) has won the approval of
the U.S. Food and Drug Administration (“FDA”) for its
motion-tolerant Nellcor pulse oximetry devices. The system can
effectively detect and diagnose acute and potentially fatal
breathing difficulties at an early stage, thereby allowing faster
treatment and elimination of respiratory complications.
The Nellcor devices from Covidien’s oximetry and monitoring
products portfolio under the Medical Devices segment are designed
to pick up cardiac-based signals and hence is highly correlated to
the patient’s physiology. Patient movement, noise and low perfusion
can hinder proper readings, which might lead to a delay in
treatment. The advanced motion-tolerant pulse oximeters provide
accurate readings, despite movements, resulting in improved
standard of care.
The Nellcor Bedside SpO2 Patient Monitoring System, Bedside
Respiratory Patient Monitoring System, and N-600x Pulse Oximetry
Monitoring System are the devices that have been cleared by the
FDA. The systems continuously monitor SpO2 as well as the pulse
rate for adult, neonatal and pediatric patients. 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.
Our Take
The FDA approval might soothe the current negative investor
sentiment on Covidien. The company recently provided a dismal
fiscal 2013 guidance, which complements its Zacks Rank #5 (Strong
Sell).
Moreover, it is slated to spin-off its Pharmaceutical unit at the
end of Jun 2013. The Pharma business is performing well and
contributing significantly to the top line. Following its
divestment, Covidien will be left with only the Medical Devices and
Supplies businesses. Given the current difficult healthcare
environment, uncertainty looms over the growth prospects of these
two businesses.
While we strongly recommend investors to avoid this stock due to
the risks associated with the Pharma spin-off, other medical stocks
such as Conceptus (CPTS),
Atricure (ATRC) and Myriad
Genetics (MYGN) warrant a look. While Conceptus carries a
Zacks Rank #1 (Strong Buy), the other two stocks carry a Zacks Rank
#2 (Buy).
ATRICURE INC (ATRC): Free Stock Analysis Report
COVIDIEN PLC (COV): Free Stock Analysis Report
CONCEPTUS INC (CPTS): Free Stock Analysis Report
MYRIAD GENETICS (MYGN): Free Stock Analysis Report
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