Masimo brain monitor obtains CE mark for pediatric indication

Patient monitoring company Masimo said that its latest SedLine brain function tracking device for anesthetized patients has obtained CE mark approval and can expand its indications for pediatric patients from 1 to 18 years old. The non-invasive technology uses a pediatric patient-specific signal processing engine to monitor the depth of sedation. The next-generation SedLine has been approved by the FDA for adults, but it is not suitable for pediatric patients in the United States.

Generally speaking, the development of pediatric medical equipment lags behind adult equipment by 5 to 10 years. The FDA held a public seminar last year to discuss this issue and promised to increase efforts to improve these numbers.

Every year, millions of children require general anesthesia for surgery or diagnostic procedures, but the use and monitoring of anesthesia for pediatric patients is different from that for adults. In order to address the safety risks of young children undergoing sedation, the FDA and the International Association for Anesthesia Research have formed a public-private partnership called SmartTots to coordinate research and focus on children under four years of age, which is an important period of brain development.


With the CE mark pediatric clearance, Masimo stated that its system is now applicable to all patients 1 year and older in CE mark countries.

The device is designed to help clinicians monitor brain function under anesthesia and process four EEG signals. The Irvine, California-based company said that a dedicated pediatric signal processing engine can improve the performance of processed EEG parameters (patient status index (PSi)) when monitoring pediatric patients. Potential improvements compared to earlier versions of the device include PSi’s lower sensitivity to EMG interference, and the multi-cone density spectral array is designed to enhance the visibility of EEG features.

Masimo is traditionally known for its pulse oximetry technology series, used to measure the oxygen saturation in the blood. The company estimates that its SET pulse oximeter has been used in more than 100 million patients worldwide. Its pulsed CO-oxygenation measurement device was launched in 2005, which provides non-invasive and continuous monitoring of blood components. Previously, only invasive measurements were possible, including total hemoglobin, oxygen content, carboxyhemoglobin, methemoglobin, volume variation index and oxygen reserve. Index, as well as SpO2, pulse rate and perfusion index.

The company’s pipeline includes wearable patient monitors, smartphone pulse oximeters and fingertip pulse oximeters.

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