Masimo gets FDA nod for brain function monitoring device

SedLine is one of the technologies covered by the agreement Masimo entered into with Philips. (Masimo)

Masimo has received 510(k) clearance to sell its next-generation brain function monitoring device. The FDA nod gives doctors an updated tool for monitoring the state of the brain in anesthetized and sedated patients.

A version of the SedLine device has been on the market for more than a decade. In short, the device acquires and processes electroencephalogram (EEG) signals to show doctors what is going in the brains of anesthetized patients. Masimo took over the franchise in 2010 when it bought SedLine, the company behind the device. Now, Masimo has moved to improve the core product.

The revised, FDA-cleared SedLine benefits from work to improve the patient state index, a computed EEG variable linked to the effect of anesthetics. 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. 

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Masimo thinks the changes add up to a notable step forward for the device. 

“With the improved performance offered by its enhanced signal processing capabilities, we expect next generation SedLine to impact brain function monitoring just as SET impacted pulse oximetry,” Masimo CEO Joe Kiani said in a statement. 

SedLine is one of the technologies covered by the agreement Masimo entered into with Philips in 2016. That agreement gave Philips the right to integrate SedLine and other Masimo technologies into its IntelliVue monitors.