Masimo Announces CE Marking of Eve CCHD Newborn Screening Application

Masimo announced the CE marking of Eve, a critical congenital heart disease (CCHD) newborn screening application, for the Rad-97 Pulse CO-Oximeter. Eve combines the power of Masimo SET Measure-through Motion and Low Perfusion pulse oximetry with a pre-ductal to post-ductal synchronization algorithm designed to reduce calculation errors.
 
Eve, also available on the Radical-7 Pulse CO-Oximeter, simplifies the CCHD screening process by providing visual instructions, animations, an automatic synchronization algorithm, and a detailed, easy-to-interpret display of screening results. The ability to label results with unique patient identifiers for both mother and newborn facilitates intuitive session management and seamless electronic charting. Eve also allows clinicians to incorporate perfusion index into screening, which has been shown to increase sensitivity to the detection of CCHD in infants with pathologically low perfusion.¹
 
CCHD affects approximately three newborns per 1,000 live births² and requires intervention soon after birth to prevent significant morbidity or mortality; later detection in infants also increases the risk of brain damage.³ In a study of 39,821 infants, CCHD screening sensitivity increased from 63 percent with physical exam alone to 83 percent with physical exam and Masimo SET pulse oximetry.⁴ In a study of 122,738 infants—   .