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Masimo's (MASI) New FDA Clearance to Boost Patient Monitoring
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Masimo Corporation (MASI - Free Report) announced that the FDA granted a De Novo to Masimo Opioid Halo, an opioid overdose prevention and alert system. This makes it the first and only FDA-cleared monitoring solution for detecting opioid-induced respiratory depression (slowed or stopped breathing), which is currently the leading cause of death from an opioid overdose.
The De Novo authorizes Opioid Halo to be made available over the counter without a prescription for patients aged 15 and up and with prescription from a healthcare provider.
The latest regulatory grant 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 Grant
Per estimates provided by Masimo, opioid overdose is the key cause of accidental death in the United States presently from both illicit opioids (such as fentanyl and heroin) and prescription opioids. Many suffer non-fatal overdose events or the loss of a close one to opioids.
Currently, opioids are readily prescribed in the United States as they can effectively help people manage pain, including after surgery or for chronic conditions. However, opioids carry severe side effects, especially opioid-induced respiratory depression. Anyone taking opioids, prescription or illicit, is at risk of experiencing an accidental overdose, the signs of which are unpredictable and can be difficult to detect.
Opioid Halo is expected to advance the forefront of continuous monitoring through its Opioid Halo engine, an advanced pattern recognition algorithm that aids in detecting and quantifying the risk of severe opioid-induced respiratory depression. Opioid Halo, together with its innovative distributed architecture, aids in managing and sending escalating alarms to caregivers, notifying them that help may be needed due to an opioid overdose. This includes triggering an automatic wellness call, which may lead to emergency medical services being dispatched.
Per management, Opioid Halo is expected to help make a big difference by providing a much-needed tool that can help millions, whether they are taking prescribed opioids or struggling with illicit opioid use.
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, seeing a CAGR of 4.4%. Factors like technological advancements and growing preference for telehealth services are expected to drive the market.
Given the market potential, the FDA granting a De Novo to Masimo Opioid Halo is likely to provide a significant boost to Masimo’s business globally.
Recent Developments
Last month, Masimo unveiled the latest addition to its wearable product line — the Masimo Freedom smartwatch.
The same month, Masimo announced the findings of a prospective study 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.
In March, Masimo entered a strategic innovation collaboration with Philadelphia-based Temple Health.
Price Performance
Shares of Masimo have gained 27.8% in the past year against the industry’s 16.8% decline and the S&P 500's 9.8% fall.
Image Source: Zacks Investment Research
Zacks Rank & Other Key Picks
Currently, Masimo flaunts a Zacks Rank #1 (Strong Buy).
A few other top-ranked stocks in the broader medical space are Hologic, Inc. (HOLX - Free Report) , Henry Schein, Inc. (HSIC - Free Report) and Avanos Medical, Inc. (AVNS - Free Report) .
Hologic, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 15.2%. HOLX’s earnings surpassed the Zacks Consensus Estimate in all the trailing four quarters, the average beat being 30.6%.
Hologic has gained 4% against the industry’s 16.8% decline in the past year.
Henry Schein, sporting a Zacks Rank #1 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 5.7% compared with the industry’s 4.9% 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 11.1% compared with the industry’s 16.8% decline over the past year.
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Masimo's (MASI) New FDA Clearance to Boost Patient Monitoring
Masimo Corporation (MASI - Free Report) announced that the FDA granted a De Novo to Masimo Opioid Halo, an opioid overdose prevention and alert system. This makes it the first and only FDA-cleared monitoring solution for detecting opioid-induced respiratory depression (slowed or stopped breathing), which is currently the leading cause of death from an opioid overdose.
The De Novo authorizes Opioid Halo to be made available over the counter without a prescription for patients aged 15 and up and with prescription from a healthcare provider.
The latest regulatory grant 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 Grant
Per estimates provided by Masimo, opioid overdose is the key cause of accidental death in the United States presently from both illicit opioids (such as fentanyl and heroin) and prescription opioids. Many suffer non-fatal overdose events or the loss of a close one to opioids.
Currently, opioids are readily prescribed in the United States as they can effectively help people manage pain, including after surgery or for chronic conditions. However, opioids carry severe side effects, especially opioid-induced respiratory depression. Anyone taking opioids, prescription or illicit, is at risk of experiencing an accidental overdose, the signs of which are unpredictable and can be difficult to detect.
Opioid Halo is expected to advance the forefront of continuous monitoring through its Opioid Halo engine, an advanced pattern recognition algorithm that aids in detecting and quantifying the risk of severe opioid-induced respiratory depression. Opioid Halo, together with its innovative distributed architecture, aids in managing and sending escalating alarms to caregivers, notifying them that help may be needed due to an opioid overdose. This includes triggering an automatic wellness call, which may lead to emergency medical services being dispatched.
Per management, Opioid Halo is expected to help make a big difference by providing a much-needed tool that can help millions, whether they are taking prescribed opioids or struggling with illicit opioid use.
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, seeing a CAGR of 4.4%. Factors like technological advancements and growing preference for telehealth services are expected to drive the market.
Given the market potential, the FDA granting a De Novo to Masimo Opioid Halo is likely to provide a significant boost to Masimo’s business globally.
Recent Developments
Last month, Masimo unveiled the latest addition to its wearable product line — the Masimo Freedom smartwatch.
The same month, Masimo announced the findings of a prospective study 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.
In March, Masimo entered a strategic innovation collaboration with Philadelphia-based Temple Health.
Price Performance
Shares of Masimo have gained 27.8% in the past year against the industry’s 16.8% decline and the S&P 500's 9.8% fall.
Image Source: Zacks Investment Research
Zacks Rank & Other Key Picks
Currently, Masimo flaunts a Zacks Rank #1 (Strong Buy).
A few other top-ranked stocks in the broader medical space are Hologic, Inc. (HOLX - Free Report) , Henry Schein, Inc. (HSIC - Free Report) and Avanos Medical, Inc. (AVNS - Free Report) .
Hologic, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 15.2%. HOLX’s earnings surpassed the Zacks Consensus Estimate in all the trailing four quarters, the average beat being 30.6%.
You can see the complete list of today’s Zacks #1 Rank stocks here.
Hologic has gained 4% against the industry’s 16.8% decline in the past year.
Henry Schein, sporting a Zacks Rank #1 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 5.7% compared with the industry’s 4.9% 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 11.1% compared with the industry’s 16.8% decline over the past year.