Danaher subsidiary Masimo has secured CE mark for its smartSedLine brain function monitor to advance anaesthetic management.
Featuring an AI-powered Patient State Index (PSi) algorithm, the device is intended to assist clinicians in monitoring brain activity during anaesthesia.
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The approval covers its availability in applicable European markets.
It continuously processes and displays four real-time bilateral frontal electroencephalogram (EEG) waveforms.
The monitor generates several key parameters, including the PSi, which provides a numerical index from 0 to 100 to reflect a patient’s level of sedation.
The new AI-powered PSi algorithm aims to increase sensitivity to changes in underlying brain signals and maintain stability during anaesthesia.
Masimo states that the enhancements are designed to allow individualised patient care and better support anaesthetic management.
Compared with its predecessor, the smartSedLine algorithm has been developed to offer improved responsiveness during induction phases and greater stability when EEG power is low.
Low EEG power is an occurrence particularly relevant for geriatric and critically ill patients.
These advancements are intended to ensure that the PSi more accurately represents a patient’s underlying brain activity and provides clinicians with relevant data for optimising patient care.
Masimo chief medical officer Dr Basil Matta said: “The brain can change rapidly under anaesthesia, and clinicians need information that responds to those changes while remaining reliable in challenging conditions.
“With smartSedLine, we are applying advanced AI techniques to brain function monitoring to deliver a more responsive Patient State Index that better reflects underlying brain activity.
“By improving responsiveness during induction and stability under low EEG power, we can provide clinicians with meaningful insights to help individualise anaesthetic management for each patient.”
Masimo’s new monitor aims to help clinicians interpret complex brain activity to inform care decisions.
The smartSedLine PSi is currently 510(k) pending in the US.
In February 2026, Danaher Corporation agreed to acquire Masimo in a cash deal worth $9.9bn to broaden its diagnostics business in the telehealth space.
