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Masimo receives CE mark approval for Eve Newborn Screening Software Application

US-based Masimo has received CE Mark approval for its Eve Newborn Screening Software Application for Radical-7 Pulse CO-Oximeters.

MDBReve

Eve has been developed to help clinicians for effectively screening newborns for critical congenital heart disease (CCHD).

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 new software application in the Radical-7 Pulse CO-Oximeter is said to automate the screening steps with animated instruction, including sensor application, measurement selection, and screening result determination.

The new software application has been designed to offer 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.

The software application is not yet available in the US.

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 by physical exam or by SpO2 measurements alone.


Image: Eve Newborn Screening Application for Radical-7 Pulse CO-Oximeter. Photo: courtesy of Masimo Corporation.