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Masimo's (MASI) SedLine Receives FDA's Pediatric Indication

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Masimo Corporation MASI recently received the FDA’s clearance for SedLine brain function monitoring for pediatric patients (1-17 years of age) and the SedLine Pediatric EEG (electroencephalogram) Sensor. The latest clearance expands access to SedLine for all patients above the age of one year in the United States.

It is noteworthy to mention that SedLine is equipped with Masimo’s advanced signal processing technology. This aids clinicians in monitoring brain activity bilaterally by processing EEG signals from Masimo’s four-lead SedLine EEG sensors.

The latest regulatory clearance for pediatric use is a major stepping stone for Masimo’s brain function monitoring business across the world.

Significance of the Approval

SedLine’s latest FDA clearance paves the way for bilateral brain activity monitoring in pediatric patients. This is in combination with specially sized pediatric sensors that have been developed for easier application on pediatric patients having smaller forehead space.

Further, as brain activity monitoring under anesthesia on pediatric patients differs from that of adults, maintaining an appropriate depth of anesthesia is essential in preventing anesthesia-related events and enabling faster recovery. SedLine features both the display of EEG signals and the Multitaper Density Spectral Array from both sides of the brain, which provides clinicians with a more comprehensive image of the brain. This aids in better monitoring anesthesia depth on children.

Per management, SedLine’s probability of achieving brain function monitoring is on par with Masimo SET’s capability for pulse oximetry. Management also believes that SedLine’s ability to monitor the depth of sedation is critical as it ensures that even patients with the most challenging and the youngest brains are appropriately anesthetized.

Industry Prospects

Per a report by MarketsandMarkets, the global brain monitoring market is projected to reach $8.0 billion by 2026 from $5.8 billion in 2021 at a CAGR of 6.5%. Factors like the growing incidence and prevalence of neurological disorders, growth in the number of traumatic brain injuries, and increasing applications of brain monitoring in clinical trials are expected to drive the market.

Given the market potential, the latest regulatory approval is likely to provide a significant boost to Masimo’s business globally.

Notable Developments

Last month, Masimo announced robust fourth-quarter 2021 results, wherein it registered a solid uptick in the top line. The company also recorded a strong rebound in sensor sales (on the back of strong demand for set sensors) and robust order shipments.

In the same month, MASI announced a major expansion of Masimo SafetyNet that brings robust, secure video conferencing to the remote patient management and connectivity platform to offer a comprehensive telehealth and telemonitoring solution. This is expected to provide a better patient experience.

Also in February, Masimo, along with Temple Health, announced that Philadelphia-based academic medical center — Temple University Hospital — is expanding the use of Masimo technologies with Centroid (an advanced wireless patient position, orientation, activity and respiration rate sensor) at 100 beds across its ICU units.

Price Performance

Shares of Masimo have lost 35.9% in the past year compared with the industry’s 4.3% fall. The S&P 500 has risen 12.9% on the same time frame.

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Zacks Rank & Key Picks

Currently, Masimo carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space include Henry Schein, Inc. HSIC, Allscripts Healthcare Solutions, Inc. MDRX and AMN Healthcare Services, Inc. AMN.

Henry Schein, having a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 11.8%. HSIC’s earnings surpassed estimates in the trailing four quarters, with the average being 25.5%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Henry Schein has gained 37.6% compared with the industry’s 11.7% growth over the past year.

Allscripts has an estimated long-term growth rate of 16.3%. MDRX’s earnings surpassed estimates in the trailing four quarters, with the average being 64.8%. It currently sports a Zacks Rank #1.

Allscripts has gained 32.4% against the industry’s 49.7% fall over the past year.

AMN Healthcare has an estimated long-term growth rate of 16.2%. AMN’s earnings surpassed estimates in the trailing four quarters, with the average being 20%. It currently flaunts a Zacks Rank #1.

AMN Healthcare has gained 45.3% against the industry’s 55.6% fall over the past year.


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