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Medical Devices / Submissions and Approvals

Masimo Gets CE Mark for Heart Disease Screening App

Feb. 8, 2018
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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.

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