Masimo receives FDA clearance for expanded O3 oximetry parameters

IRVINE, Calif. - Masimo (NASDAQ:MASI), a medical technology company with a market capitalization of $8.36 billion, has received FDA 510(k) clearance for expanded indications of its delta hemoglobin parameters provided with O3 Regional Oximetry, the company announced Tuesday. According to InvestingPro data, Masimo maintains strong liquidity with a current ratio of 2.14, suggesting robust operational stability as it expands its product offerings.

The parameters, which display relative changes in hemoglobin, are now available for both cerebral and somatic applications across all patient populations, including pediatric and neonatal patients. This expansion comes as the company, which generated $2.15 billion in revenue over the last twelve months, continues to strengthen its market position. InvestingPro analysis reveals that 8 analysts have recently revised their earnings expectations upward for the upcoming period.

Masimo’s O3 technology, available on the company’s Root patient monitoring platform, uses near-infrared spectroscopy to monitor continuous regional oxygen saturation values in tissue. The delta hemoglobin parameters provide additional insight by monitoring relative changes in total hemoglobin, deoxygenated hemoglobin, and oxygenated hemoglobin.

These measurements can help clinicians better understand why a patient’s oxygen saturation is changing and determine appropriate interventions.

A 2024 randomized controlled trial from Korean researchers found that using these parameters improved maintenance of cerebral physiology in elderly patients undergoing surgery with general anesthesia compared to traditional regional oximetry.

Similarly, a 2022 study published in Anesthesia & Analgesia highlighted benefits of these parameters in cardiac surgery patients, noting they help overcome limitations of traditional cerebral oximeters that cannot reveal exact causes of cerebral desaturation.

Dr. Basil Matta, SVP of Global Clinical Affairs & Solutions for Masimo, stated that combining O3 with SedLine Brain Function Monitoring on the Root platform offers "a true Brain Health Platform and provides a truly multimodal view of the brain."

The company claims its O3 Regional Oximetry provides both trending and absolute accuracy specifications, with trending accuracy of 3% ARMS for all applications and absolute accuracy specifications of 4-5% ARMS depending on patient type and monitoring site.

This announcement was made in a company press release. For investors seeking deeper insights into Masimo’s financial health and growth prospects, InvestingPro offers comprehensive analysis through its Pro Research Report, part of its coverage of over 1,400 US equities. The platform provides detailed valuation metrics, growth indicators, and expert analysis of healthcare sector companies like Masimo, helping investors make informed decisions in this dynamic medical technology space.

In other recent news, Masimo Corp. reported strong second-quarter 2025 financial results, surpassing analyst expectations with sales of $370.9 million. This figure exceeded both Stifel’s and consensus estimates, representing a 7.7% year-over-year increase, excluding foreign exchange effects. In response to these results, Stifel reiterated its Buy rating with a price target of $180.00. Needham also maintained its Hold rating on Masimo, noting the company’s better-than-anticipated revenue and earnings per share, despite a slowdown in overall revenue growth to 7% on a constant currency basis. Jefferies raised its price target for Masimo to $170.00 from $158.00, citing a lower tariff impact, while maintaining a Hold rating. Additionally, BTIG reiterated its Buy rating with a $198.00 price target following Apple’s announcement to reintroduce the Blood Oxygen feature for certain Apple Watch models. This feature had been previously removed due to a legal battle with Masimo. The reintroduction will occur through software updates for Apple Watch users in the United States.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.