www.fdanews.com/articles/185530-masimo-gets-ce-mark-for-heart-disease-screening-app
Masimo Gets CE Mark for Heart Disease Screening App
February 7, 2018
Masimo, a Switzerland-based global developer of health monitoring technologies,received a CE Mark for its critical congenital heart disease newborn screening application called Eve.
The new mark allows for Eve to be used in the EU with the company’s Rad-97 Pulse CO-Oximeter device.
Eve features an automated synchronization algorithm designed to reduce calculation errors and it simplifies the screening process by providing visual instructions, animations, and an easy-to interpret display of screening results.