Masimo smartSedLine CE Mark Clears AI Brain Monitor in EU

The Masimo smartSedLine CE mark is in. Danaher subsidiary Masimo has secured the CE mark for its smartSedLine brain function monitor. The device targets anaesthetic management. Clearance covers availability in applicable European markets.

At the heart of the device is an AI-powered Patient State Index (PSi) algorithm. It aims to help clinicians track brain activity during anaesthesia. The Masimo smartSedLine CE mark now clears the path for European rollout.

What smartSedLine displays

The monitor runs and shows four real-time bilateral frontal EEG waveforms. That is short for electroencephalogram. It also generates several key parameters.

The headline number is the PSi. That is a numerical index from 0 to 100. It reflects a patient's level of sedation. Anaesthesia teams can read it at a glance during a case.

Inside the AI-powered PSi algorithm

The new AI-powered PSi algorithm targets two things at once. First, it aims to spot shifts in underlying brain signals faster. Second, it aims to hold stability during anaesthesia.

Compared with the older version, the smartSedLine algorithm reacts faster during induction phases. It also holds stability better when EEG power is low. Low EEG power is common in older and critically ill patients.

Masimo said these upgrades are designed to allow tailored patient care. They also aim to better support anaesthetic management. In short, the PSi maps brain activity more closely. That gives clinicians better bedside data.

Matta on the clinical rationale

Masimo chief medical officer Dr Basil Matta framed the launch around the reality of anaesthesia. Brain state can shift fast in the operating room. That puts stress on the tools.

Matta said: "The brain can change rapidly under anaesthesia, and clinicians need information that responds to those changes while remaining reliable in challenging conditions."

Matta added: "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."

Matta closed on the two big design goals.

Matta added: "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."

US pending and Danaher deal context

The Masimo smartSedLine CE mark lands ahead of a pending US filing. The smartSedLine PSi is currently 510(k) pending with the FDA.

The launch sits inside a bigger deal story. In February 2026, Danaher Corporation agreed to acquire Masimo. The cash deal was worth $9.9bn. The stated aim was to broaden Danaher's diagnostics business in the telehealth space.

Why the Masimo smartSedLine CE mark matters

Depth-of-anaesthesia monitoring guides sedation choices. It helps avoid awareness under anaesthesia. It also helps cut over-sedation and long emergence times. In older and critically ill patients, low EEG signal has long been a snag for these tools.

An AI-driven PSi tuned for induction speed and low-power stability could sharpen bedside choices. For anaesthesiology, ICU, and hospital procurement teams, the Masimo smartSedLine CE mark is the near-term milestone. Coverage on Medigear.uk tracks the US 510(k) path and the wider Danaher-Masimo deal.

Source: Originating coverage based on Medical Device Network reporting by Salong Debbarma, August 19, 2026, on Masimo's CE mark for the smartSedLine brain function monitor. URL: https://www.medicaldevice-network.com/