US-based Masimo has secured CE Mark appoval for its Eve newborn screening software application for Radical-7 Pulse CO-Oximeters.
With the new Eve application, clinicians can effectively screen newborns for critical congenital heart disease (CCHD).
The company said newborn screening protocols may present challenges including longer-than-necessary monitoring times, misapplication of sensors, calculation errors, and confusion when interpreting results.
Newborn Foundation CEO Annamarie Saarinen said: "Too many babies have been discharged from hospitals without proper pulse oximetry screening, only to die or require last-minute, emergency life-saving procedures.
"Failing to follow and interpret a proper screening protocol, as well as being able to read measurements in newborns who are often in motion and have low perfusion are factors that can make CCHD screening with pulse oximetry a challenge.
"The data and study evidence show that having the right pulse oximetry technology for CCHD screening is critical, and it’s very exciting to see the introduction of Eve, a new tool that offers nurses a clearer, safer, more efficient way to conduct newborn screening and protect newborn lives."
The new Eve software application in the Radical-7 Pulse CO-Oximeter claims to automate the screening steps with animated instructions, including sensor application, measurement selection, and screening result determination.
Eve has been designed to provide consistent application of the screening protocol to reduce method and operator-induced variability, and improve efficiency by automating the data capture and comparison between readings.
Masimo founder and CEO Joe Kiani said: "Annamarie and her daughter Eve have inspired us to name the new automated CCHD detection application, Eve.
"Annamarie has worked tirelessly to make CCHD screening the standard of care worldwide. We salute her and Dr Granelli, and hope that Eve will help these professionals accomplish their mission to help save the lives of babies and spare families from heartbreaking loss."
The Perfusion Index (PI) measurement is also available in all Masimo SET pulse oximeters, which will be used to identify CCHD or other illnesses that cannot be identified through a physical examination or by SpO2 measurements alone.
Image: Eve newborn screening application automates each of the screening steps with animated, iunstruction including sensor application, measurement selection, and screening result determination. Photo: courtesy of Masimo Corporation.