Masimo's (MASI) New FDA Approval to Improve Patient Monitoring
Masimo Corporation MASI recently announced the receipt of the FDA’s 510(k) clearance for its Rad-G with Temperature. The device is a versatile handheld monitor that provides SET pulse oximetry, respiration rate from the pleth and other important parameters alongside non-contact infrared clinical thermometry.
The Rad-G with Temperature was first developed in partnership with The Bill & Melinda Gates Foundation as a spot-check device in pneumonia screening and was launched outside the United States. The device has seen robust customer adoption since its introduction in Europe to help them assess patient status in various care settings.
The latest regulatory clearance is a major stepping stone for Masimo’s real-time patient monitoring business and is likely to solidify its position in the niche space on a global scale.
Significance of the Approval
The Rad-G with Temperature has been equipped with a long-lasting rechargeable battery and the added convenience of integrated non-invasive forehead thermometry. This makes it easier for care teams to quickly measure vital signs using a single, compact and portable device to make informed patient assessment decisions wherever needed. The device has been designed for use in a variety of settings, including physicians’ offices, outpatient services and first-responder scenarios, both indoors and in the field, among others.
Per management, following the FDA clearance, the Rad-G with Temperature can now be deployed across the United States, in addition to various other parts across the world, to aid clinicians in almost any care scenario.
Industry Prospects
Per a report by Allied Market Research, the global patient monitoring devices market was estimated to be $25,768.56 million in 2019 and is anticipated to reach $44,861.56 million by 2027 at a CAGR of 4.4%. Factors like technological advancements and a growing preference for telehealth services are expected to drive the market.
Given the market potential, the latest FDA approval is likely to provide a significant boost to Masimo’s business globally.
Recent Developments
This month, Masimo announced that the FDA had granted a De Novo to Masimo Opioid Halo, an opioid overdose prevention and alert system.
Last month, Masimo unveiled the newest addition to its wearable product line — the Masimo Freedom smartwatch.
The same month, Masimo announced the findings of a prospective study that was published in Pediatrics International. The research relates to the ability of non-invasive, continuous Masimo pleth variability index and other dynamic parameters to predict fluid responsiveness in children of one to three years of age who were undergoing major neurosurgery.
Price Performance
Shares of Masimo have gained 50.7% in the past year against the industry’s 11.3% decline and the S&P 500's 6% fall.
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Zacks Rank & Other Key Picks
Currently, Masimo sports a Zacks Rank #1 (Strong Buy).
A few other top-ranked stocks in the broader medical space are IDEXX Laboratories, Inc. IDXX, Henry Schein, Inc. HSIC and Avanos Medical, Inc. AVNS.
IDEXX Laboratories, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 18%. IDXX’s earnings surpassed the Zacks Consensus Estimate in all the trailing four quarters, the average beat being 3.6%. You can see the complete list of today’s Zacks #1 Rank stocks here.
IDEXX Laboratories has lost 0.9% compared with the industry’s 11.3% decline in the past year.
Henry Schein, carrying a Zacks Rank #2 at present, has an estimated long-term growth rate of 8.1%. HSIC’s earnings surpassed estimates in three of the trailing four quarters and matched the same in the other, the average beat being 2.9%.
Henry Schein has lost 8.6% compared with the industry’s 2% decline over the past year.
Avanos, carrying a Zacks Rank #2 at present, has an estimated growth rate of 1.8% for 2023. AVNS’ earnings surpassed estimates in all the trailing four quarters, the average beat being 11%.
Avanos has lost 6% compared with the industry’s 11.3% decline over the past year.
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Henry Schein, Inc. (HSIC) : Free Stock Analysis Report
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