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Masimo's (MASI) O3 Regional Oximetry Attains FDA Approval

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Masimo Corporation (MASI - Free Report) recently announced that its O3 Regional Oximetry has received FDA approval for expanded use in monitoring somatic tissue oxygenation saturation in all patient population and assessing relative changes in hemoglobin, oxyhemoglobin, and deoxyhemoglobin in adult brains. With this FDA approval, O3 is now cleared for use in both cerebral and somatic applications, in the United States and other countries, with respect to all patient population.

This development is expected to boost the company’s patient monitoring platform.

More on O3 Regional Oximetry

O3 Regional Oximetry provides regional or tissue hemoglobin oxygen saturation with a trending specification of 3% ARMS (cerebral and somatic, all ages) and absolute accuracy specifications of 4% ARMS (cerebral, adults) and 5% ARMS (cerebral, pediatric patients) through the utilization of O3 multi-wavelength sensors and O3 Regional Oximetry near-infrared spectroscopy (NIRS) technology. It is important to note here that ARMS accuracy is a statistical calculation of the difference between device measurements and reference measurements.

Unlike peripheral pulse oximetry, which gives an indication of the body’s general arterial blood oxygenation, O3 offers information about the local tissue’s hemoglobin oxygen saturation, both in cerebral and somatic applications. This information provides detailed insight that may help apprise clinicians of changes in cerebral or somatic tissue oxygen levels. Monitoring both brain and somatic tissue oxygenation simultaneously may further enhance clinicians’ ability to offer swift and precise patient care.

O3 effortlessly integrates with MasimoSedLine brain function monitoring on the Root Patient Monitoring and Connectivity Platform. The platform is a powerful, expandable hub that integrates a wide range of technologies, devices, and systems to provide multimodal monitoring and connectivity solutions.

The expanded indication received by O3 signifies a key milestone that will help clinicians and researchers bring additional information with respect to the use of oxygen by the body and also in uncovering organ hypoxemia.

Recent Developments

In June 2020, the company launched Masimo SafetyNet-Open, which has been designed to help businesses, governments and schools manage employee and student health and safety better during the COVID-19 pandemic.This is expected to strengthen the company’s position in the non-invasive patient monitoring space.

In April, the company announced the full market release of Masimo SafetyNet, which is an economically scalable cloud-based patient management solution, created to enable clinicians to provide care for patients in hospital settings and non-traditional settings remotely. This innovative solution is now available globally and is likely to aid clinicians and health workers in fighting the pandemic. This solution is likely to boost Masimo’s patient monitoring product spectrum.

Market Prospects

Per a report by Grand View Research, the global remote patient-monitoring system market is anticipated to reach $1.8 billion by 2026 from 2019, at a CAGR of 13.5%. Hence, this approval is well-timed.

Price Performance

Over the past year, shares of this company have surged 46.2% compared with the industry’s growth of 22.1%.

Zacks Rank and Key Picks

Masimo currently holds a Zacks Rank #5 (Strong Sell).

A few better-ranked stocks from the broader medical space include OPKO Health (OPK - Free Report) , Surmodics (SRDX - Free Report)  and Merit Medical Systems (MMSI - Free Report) .

OPKO Health’s long-term earnings growth rate is estimated at 12%. The company presently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Surmodics’ long-term earnings growth rate is estimated at 10%. The company presently carries a Zacks Rank #2.

Merit Medical Systems’ long-term earnings growth rate is estimated at 11.9%. It currently carries a Zacks Rank #2.

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