Covidien (NYSE:COV) landed a 510(k) for its Nellcor pulse oximeter, which the federal watchdog agency OK’d for diagnosis of infant critical congenital heart disease (CCHD).
The Mansfield, Mass.-based med-tech titan already sells other devices in the Nellcor patient monitoring line, and is touting the pulse oximeter as the first ISO 8601-2-61 compliant oximeter in the U.S. market.
Covidien has demonstrated that its Nellcor pulse oximeter is still accurate even when the patient is moving, and the company is now pushing a new enhanced screening campaign and an online educational resource platform for CCHD.
"Covidien is committed to raising public awareness about this issue and encouraging CCHD screenings. We truly hope our CCHD resources, the educational support we offer clinicians and our pulse oximetry portfolio help make an important difference in the fight against CCHD," Matthew Anderson, VP of respiratory monitoring solutions, said in a company statement.
Covidien launched its Nellcor respiratory system in stages in March 2012 and later that year won 510(k) clearance for another Nellcor patient monitor, the Bedside SpO2.GE Healthcare (NYSE:GE) integrated the Nellcor SpO2 monitors into its Giraffe and Panda infant warmers, aiming to help clinicians safely monitor and screen infants.
