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# Masimo Brain Function Monitor Cleared by FDA
- URL: https://www.fdaweb.com/masimo-brain-function-monitor-cleared-by-fda/
- Published: 2018-01-31T12:00:00.000Z
- Updated: 2026-09-14T23:18:25.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140652

Masimo has received 510(k) clearance to sell its next-generation SedLine brain function monitoring device for use in anesthetized and sedated patients. The device acquires and processes electroencephalogram (EEG) signals, providing physicians brain function data on anesthetized patients. The revised SedLine “benefits from work to improve the patient state index, a computed EEG variable linked to the effect of anesthetics,” the company says. “Masimo has also worked with doctors at Massachusetts General Hospital on multitaper density spectral array, the technology SedLine uses to transform EEG data in a way that may improve the display of its features,” it says.