Covidien touts 510(k) win for Nellcor respiration rate software

March 20, 2012 by MassDevice staff

Covidien plans a limited release of its Nellcor respiration rate system following its FDA 510(k) win.

Covidien's Nellcor

Covidien (NYSE:COV) landed an FDA win for its Nellcor respiration system with version 1.0 software and adult respiratory sensor.

The Mansfield, Mass.-based med-tech titan is preparing a limited market release in the U.S. next month, allowing select hospitals to use the Nellcor system, according to a press release.

"Despite its clinical importance, current methods of respiration rate monitoring are not always adequate," Dr. Scott Kelley, Covidien's chief medical officer, said in prepared remarks. "Instead of merely knowing a patient's blood oxygen levels, we can now look at aspects of ventilation, or the passing of air into and out of the body. This gives health care professionals a more complete picture of a patient's respiratory status, so they can provide effective treatment and maintain patient safety ."

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The Nellcor system tracks changes in patients' pulse oximetry signals to determine respiration rate changes, allowing clinicians to head off potentially life-threatening respiratory problems. Covidien won CE Mark approval to launch the device in the European Union in December 2011.

News of the CE Mark sent COV shares up 4%, but there hasn't been a complementary response to the FDA win on Wall Street. COV shares were flat at $53.73 as of about noon today.