Masimo's (MASI) MightySat Pulse Oximeter Receives FDA Approval

Masimo Corporation MASI recently announced the FDA clearance of its Masimo SET-powered MightySat Medical Pulse Oximeter, available Over-The-Counter (OTC) to consumers without a prescription.

This oximeter becomes the first FDA-approved medical fingertip pulse oximeter that can be directly availed by consumers without the need for any formal prescription. All other pulse oximeters marketed directly to consumers and found at drugstores or online have no FDA clearance.

Price Performance

For the past six months, MASI’s shares have gained 19.7% compared with the industry’s rise of 3.0%. The S&P 500 increased 11.6% in the same time frame.

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More on the News

Pulse oximeters that are generally available at drug stores, online or availed by consumers directly have been reported to give erroneous measurements. These oximeters are not FDA-approved and, hence, cannot be completely trusted for medical usage.

With the FDA nod, consumers will be able to purchase a medical device that measures pulse oximetry using Masimo SET pulse oximetry, the same technology that clinics and hospitals use globally to monitor more than 200 million patients annually. It has been proven to have minimal clinical discrepancy in accuracy.

The FDA released a safety communication in 2021, outlining the common limitations of both prescription and "health and wellness" pulse oximeters, including challenges with accurate measurement during patient motion in patients with low perfusion and patients with darker skin pigmentation. The FDA clarified that it does not review the accuracy of "health and wellness" pulse oximeters.

Masimo SET, a medical device with hospital-grade pulse oximetry technology that MightySat Medical offers directly to consumers, has undergone FDA evaluation and clearance for medical use. For individuals with limited perfusion as well as those with any skin tone, MightySat Medical offers precise and trustworthy assessments of oxygen saturation (SpO2) and pulse rate.

Masimo MightySat Medical is designed for spot measurements of pulse rate and functional oxygen saturation of arterial hemoglobin. Those who are 18 years or older and are well or weakly perfused should use MightySat Medical under no motion conditions. MightySat Medical is not intended for the diagnosis or screening of lung disease.

This pulse oximeter can be purchased at the company’s website, and it will soon be available for purchase at retail and drug stores across the country.

Industry Prospects

Per a report by Grand View Research, the global pulse oximeter market size was valued at $2.4 billion in 2022 and is expected to grow at 6.4% from 2023 to 2030.

The primary driver of theglobal marketis the rising prevalence of respiratory diseases like COPD, asthma, and others. The market demand is also being driven by increased hospitalizations and surgical operations, as well as technological developments in pulse oximeter devices.

The FDA approval for Masimo SET may lead to higher demand for the product in the pulse oximeter segment, thereby generating higher sales. Given the market potential, the latest FDA clearance for its pulse oximeter is likely to provide a significant boost to Masimo’s business.

Notable Developments

In December 2023, Masimo announced the receipt of the FDA’s clearance for Stork for prescription use with healthy and sick infants aged 0-18 months of age. Stork, Masimo’s innovative baby monitoring system, leverages its advanced sensor technology already in use for monitoring in hospitals.

Masimo Corporation Price

Masimo Corporation Price

Masimo Corporation price | Masimo Corporation Quote

Zacks Rank & Other Stocks to Consider

MASI sports a Zacks Rank #1 (Strong Buy) at present.

Some other top-ranked stocks to consider in the broader medical space are Universal Health Services UHS, Integer Holdings Corporation ITGR and Elevance Health, Inc ELV.

Universal Health Services, carrying a Zacks Rank #2 (Buy) at present, has an estimated growth rate of 4.4% for 2024. UHS’s earnings surpassed estimates in all the trailing four quarters, delivering an average surprise of 5.47%. You can see the complete list of today’s Zacks #1 Rank stocks here.

UHS’s shares have gained 1.9% in the past six months against the industry’s 5% decline.

Integer Holdings, presently carrying a Zacks Rank of 2, has an estimated long-term growth rate of 15.8%. ITGR’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 11.9%.

Integer Holdings’ shares have rallied 43.5% in the past year against the industry’s 3.7% decline.

Elevance Health, carrying a Zacks Rank of 2, reported fourth-quarter 2023 adjusted earnings per share of $5.62, beating the Zacks Consensus Estimate by 1.3%. Revenues of $42.45 billion outpaced the consensus mark by 1.5%.

Elevance Health has a long-term estimated growth rate of 12%. ELV’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 3.1%.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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