Masimo gets FDA clearance for pediatric patient state index platform

Danaher’s (NYSE:DHR) Masimo unit announced today that it received FDA 510(k) clearance for its Patient State Index (PSi) for pediatric patients.

Irvine, California-based Masimo — which became a part of Danaher through a $10 billion acquisition last month —  said the PSi represents the first-and-only sedation score specifically designed for the unique physiology of the pediatric brain. It works as a key function of the Masimo SedLine brain function monitoring platform.

SedLine processes and displays EEG signals from both halves of the brain. It also offers a multi-taper Density Spectral Array (DSA) and PSi. The platform offers clinicians a more complete picture of the brain under anesthesia, Masimo says.

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