We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Masimo Shares Dip Despite FDA Clears Expanded Use of O3 Monitoring
Read MoreHide Full Article
Key Takeaways
Masimo secured FDA clearance for expanded use of O3 Regional Oximetry with delta hemoglobin.
The approval covers cerebral and somatic applications across all ages, including neonates.
O3 now provides deeper insight into oxygen imbalances, aiding precise interventions in critical care.
Masimo (MASI - Free Report) recently secured FDA 510(k) clearance for expanded indications of its O3 Regional Oximetry with delta hemoglobin parameters. These parameters track relative changes in hemoglobin levels, helping clinicians better identify the causes behind shifts in tissue oxygen saturation. With this approval, the advanced monitoring capability is now cleared for both cerebral and somatic applications across all patient populations, including pediatrics and neonates.
Built on Masimo’s Root platform, O3 uses near-infrared spectroscopy to measure continuous regional oxygen saturation (rSO2), reflecting the balance between oxygen delivery and demand. By adding delta hemoglobin parameters, clinicians gain deeper insight into whether changes stem from oxygenated, deoxygenated, or total hemoglobin levels, aiding more precise interventions. The FDA nod strengthens Masimo’s position in brain health monitoring, complementing its SedLine Brain Function Monitoring system and advancing its integrated "Brain Health Platform" for critical care and anesthesia settings.
Likely Trend of MASI Stock Following the News
Following the announcement, the company's shares lost 4.6% at yesterday’s market closing. Shares have lost 11.2% in the year-to-date period compared with the industry’s 7.6% decline. The S&P 500 has gained 9.5% in the same time frame.
This FDA clearance could act as a meaningful growth catalyst for Masimo by broadening the clinical utility of its O3 platform across more patient groups, including pediatrics and neonates. By giving clinicians deeper insights into the causes of oxygen imbalances, the expanded indications make O3 more valuable in operating rooms, ICUs, and other critical care settings. That, in turn, not only strengthens adoption of Masimo’s Root platform but also drives recurring revenue from monitoring solutions, positioning the company to capture a larger share of the high-margin brain and tissue monitoring market.
MASI currently has a market capitalization of $8.36 million. In the last reported quarter, MASI delivered an earnings surprise of 8.13%.
Image Source: Zacks Investment Research
More on Masimo's O3 Regional Oximetry
O3 Regional Oximetry uses near-infrared spectroscopy to continuously measure regional oxygen saturation values in targeted tissues. These values, referred to as rSO2, reflect the balance between oxygen delivery and metabolic demand in the monitored organ. However, rSO2 alone may not always explain the cause of an imbalance. The addition of delta hemoglobin parameters: cHb (total hemoglobin), HHb (deoxygenated hemoglobin), and O2Hb (oxygenated hemoglobin), allows clinicians to monitor relative changes in the key components that drive rSO2, providing deeper insight into the mechanisms behind oxygen saturation shifts.
The FDA clearance expands the use of these parameters to both cerebral and somatic monitoring and across all patient populations, including pediatric and neonatal patients. This broader indication enhances the clinical relevance of O3, particularly in scenarios such as venous congestion, where increases in total hemoglobin can signal blood pooling associated with negative outcomes. O3 delivers both trending and absolute accuracy, with specifications of 3% ARMS for trending across all ages and 4 to 5% ARMS for absolute accuracy, depending on patient type and monitoring region. These validated accuracy levels provide clinicians with confidence that the values reflect actual physiological conditions.
Clinical studies highlight O3’s added value. A 2024 trial in Korea showed that delta hemoglobin parameters improved management of cerebral physiology in elderly surgical patients, while a 2022 study in Anesthesia & Analgesia found the technology helped pinpoint the causes of cerebral desaturation more effectively than traditional oximeters. Combined with SedLine Brain Function Monitoring on the Root platform, O3 provides a comprehensive view of brain oxygen delivery and demand.
Favorable Industry Prospects for MASI
Per a report by Global Market Insights, the global cerebral oximetry monitoring market was valued at $239.4 million in 2024 and is set to register a CAGR of 6.7% from 2025 to 2034.
This incremental growth rate is owing to the increasing prevalence of neurological ailments, coupled with an increasing number of surgeries globally.
MASI’s Zacks Rank & Key Picks
Currently, MASI carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space that have announced quarterly results are Medpace Holdings, Inc. (MEDP - Free Report) , West Pharmaceutical Services, Inc. (WST - Free Report) and Boston Scientific Corporation (BSX - Free Report) .
Medpace Holdings, sporting a Zacks Rank of 1 (Strong Buy), reported second-quarter 2025 EPS of $3.10, beating the Zacks Consensus Estimate by 3.3%. Revenues of $603.3 million outpaced the consensus mark by 11.5%. You can see the complete list of today’s Zacks #1 Rank stocks here.
Medpace Holdings has a long-term estimated growth rate of 11.4%. MEDP’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 13.9%.
West Pharmaceutical reported second-quarter 2025 adjusted EPS of $1.84, beating the Zacks Consensus Estimate by 21.9%. Revenues of $766.5 million surpassed the Zacks Consensus Estimate by 5.4%. It currently flaunts a Zacks Rank #1.
West Pharmaceutical has a long-term estimated growth rate of 8.5%. WST’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 16.8%.
Boston Scientific reported second-quarter 2025 adjusted EPS of 75 cents, beating the Zacks Consensus Estimate by 4.2%. Revenues of $5.06 billion surpassed the Zacks Consensus Estimate by 3.5%. It currently carries a Zacks Rank #2 (Buy).
Boston Scientific has a long-term estimated growth rate of 14%. BSX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 8.1%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
Masimo Shares Dip Despite FDA Clears Expanded Use of O3 Monitoring
Key Takeaways
Masimo (MASI - Free Report) recently secured FDA 510(k) clearance for expanded indications of its O3 Regional Oximetry with delta hemoglobin parameters. These parameters track relative changes in hemoglobin levels, helping clinicians better identify the causes behind shifts in tissue oxygen saturation. With this approval, the advanced monitoring capability is now cleared for both cerebral and somatic applications across all patient populations, including pediatrics and neonates.
Built on Masimo’s Root platform, O3 uses near-infrared spectroscopy to measure continuous regional oxygen saturation (rSO2), reflecting the balance between oxygen delivery and demand. By adding delta hemoglobin parameters, clinicians gain deeper insight into whether changes stem from oxygenated, deoxygenated, or total hemoglobin levels, aiding more precise interventions. The FDA nod strengthens Masimo’s position in brain health monitoring, complementing its SedLine Brain Function Monitoring system and advancing its integrated "Brain Health Platform" for critical care and anesthesia settings.
Likely Trend of MASI Stock Following the News
Following the announcement, the company's shares lost 4.6% at yesterday’s market closing. Shares have lost 11.2% in the year-to-date period compared with the industry’s 7.6% decline. The S&P 500 has gained 9.5% in the same time frame.
This FDA clearance could act as a meaningful growth catalyst for Masimo by broadening the clinical utility of its O3 platform across more patient groups, including pediatrics and neonates. By giving clinicians deeper insights into the causes of oxygen imbalances, the expanded indications make O3 more valuable in operating rooms, ICUs, and other critical care settings. That, in turn, not only strengthens adoption of Masimo’s Root platform but also drives recurring revenue from monitoring solutions, positioning the company to capture a larger share of the high-margin brain and tissue monitoring market.
MASI currently has a market capitalization of $8.36 million. In the last reported quarter, MASI delivered an earnings surprise of 8.13%.
Image Source: Zacks Investment Research
More on Masimo's O3 Regional Oximetry
O3 Regional Oximetry uses near-infrared spectroscopy to continuously measure regional oxygen saturation values in targeted tissues. These values, referred to as rSO2, reflect the balance between oxygen delivery and metabolic demand in the monitored organ. However, rSO2 alone may not always explain the cause of an imbalance. The addition of delta hemoglobin parameters: cHb (total hemoglobin), HHb (deoxygenated hemoglobin), and O2Hb (oxygenated hemoglobin), allows clinicians to monitor relative changes in the key components that drive rSO2, providing deeper insight into the mechanisms behind oxygen saturation shifts.
The FDA clearance expands the use of these parameters to both cerebral and somatic monitoring and across all patient populations, including pediatric and neonatal patients. This broader indication enhances the clinical relevance of O3, particularly in scenarios such as venous congestion, where increases in total hemoglobin can signal blood pooling associated with negative outcomes. O3 delivers both trending and absolute accuracy, with specifications of 3% ARMS for trending across all ages and 4 to 5% ARMS for absolute accuracy, depending on patient type and monitoring region. These validated accuracy levels provide clinicians with confidence that the values reflect actual physiological conditions.
Clinical studies highlight O3’s added value. A 2024 trial in Korea showed that delta hemoglobin parameters improved management of cerebral physiology in elderly surgical patients, while a 2022 study in Anesthesia & Analgesia found the technology helped pinpoint the causes of cerebral desaturation more effectively than traditional oximeters. Combined with SedLine Brain Function Monitoring on the Root platform, O3 provides a comprehensive view of brain oxygen delivery and demand.
Favorable Industry Prospects for MASI
Per a report by Global Market Insights, the global cerebral oximetry monitoring market was valued at $239.4 million in 2024 and is set to register a CAGR of 6.7% from 2025 to 2034.
This incremental growth rate is owing to the increasing prevalence of neurological ailments, coupled with an increasing number of surgeries globally.
MASI’s Zacks Rank & Key Picks
Currently, MASI carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space that have announced quarterly results are Medpace Holdings, Inc. (MEDP - Free Report) , West Pharmaceutical Services, Inc. (WST - Free Report) and Boston Scientific Corporation (BSX - Free Report) .
Medpace Holdings, sporting a Zacks Rank of 1 (Strong Buy), reported second-quarter 2025 EPS of $3.10, beating the Zacks Consensus Estimate by 3.3%. Revenues of $603.3 million outpaced the consensus mark by 11.5%. You can see the complete list of today’s Zacks #1 Rank stocks here.
Medpace Holdings has a long-term estimated growth rate of 11.4%. MEDP’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 13.9%.
West Pharmaceutical reported second-quarter 2025 adjusted EPS of $1.84, beating the Zacks Consensus Estimate by 21.9%. Revenues of $766.5 million surpassed the Zacks Consensus Estimate by 5.4%. It currently flaunts a Zacks Rank #1.
West Pharmaceutical has a long-term estimated growth rate of 8.5%. WST’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 16.8%.
Boston Scientific reported second-quarter 2025 adjusted EPS of 75 cents, beating the Zacks Consensus Estimate by 4.2%. Revenues of $5.06 billion surpassed the Zacks Consensus Estimate by 3.5%. It currently carries a Zacks Rank #2 (Buy).
Boston Scientific has a long-term estimated growth rate of 14%. BSX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 8.1%.