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Masimo's (MASI) Stork Baby Monitoring System Approved by FDA
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Masimo Corporation (MASI - Free Report) recently 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.
It is worth noting that Stork is currently available at retailers nationwide as a non-medical device for general health and wellness purposes. However, with this clearance, Stork will now be available for prescription use to continuously monitor babies at home as a medical device for healthy or sick babies.
For non-medical use, Masimo Stork bundles are available for direct consumer purchase at MasimoStork.com and on shelves at major and specialty U.S. retailers.
The latest regulatory clearance of Masimo’s home baby monitoring system is expected to significantly strengthen its remote baby monitoring business across the nation.
Significance of FDA Approval
Stork leverages the same technology that has been used on babies in the neonatal intensive care unit over the years. This is expected to help improve health outcomes for the youngest and most vulnerable patients.
Per Masimo, Stork, when prescribed, will now enable parents and family members to receive alarms regarding their baby’s oxygen saturation, pulse rate and skin temperature. They will also be likely to share these vital signs data remotely with clinicians. Stork is also expected to alert parents if their baby turns over and is sleeping face down, which can be dangerous for babies.
Per management, infant monitoring can be expensive and inconvenient due to the use of traditional hospital-grade equipment. Management believes that Stork will likely provide parents with an affordable and easy-to-use solution for monitoring their baby's health, particularly when they are unwell. This is expected to cost significantly less than traditional methods.
Industry Prospects
Per a report by Grand View Research, the global smart baby monitor market was estimated at $1,347.1 million in 2022 and is anticipated to grow at a CAGR of 7.9% between 2023 and 2030. Factors like the growing emphasis on child safety and security, the rise in the number of working families and the increasing adoption of smart home technologies are expected to drive the market.
Given the market potential, the latest FDA clearance for its smart baby monitor is likely to provide a significant boost to Masimo’s business.
Recent Developments
This month, Masimo announced the findings of a retrospective study in which researchers assessed the association between Masimo ORi (Oxygen Reserve Index) and the arterial partial pressure of oxygen in patients who underwent non-cardiac thoracic surgery during one-lung ventilation. The findings were published in the Journal of Anesthesia.
Last month, Masimo announced the receipt of the FDA’s 510(k) clearance for over-the-counter and prescription use of the Masimo W1 medical watch.
The same month, Masimo reported its third-quarter 2023 results. Per management, its healthcare business is transitioning away from COVID-era conditions. Also, management is beginning to see customer behavior and sensor purchasing patterns shifting back to the pre-pandemic growth trend line.
Price Performance
Shares of Masimo have lost 20.9% in the past year against the industry’s 4.1% rise and the S&P 500’s 24.6% growth.
Image Source: Zacks Investment Research
Zacks Rank & Stocks to Consider
Currently, Masimo carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the broader medical space are DaVita Inc. (DVA - Free Report) , DexCom, Inc. (DXCM - Free Report) and Integer Holdings Corporation (ITGR - Free Report) .
DaVita, sporting a Zacks Rank #1 (Strong Buy), has an estimated long-term growth rate of 17.3%. DVA’s earnings surpassed estimates in all the trailing four quarters, with an average surprise of 36.6%. You can see the complete list of today’s Zacks #1 Rank stocks here.
DaVita’s shares have gained 50.9% compared with the industry’s 9.7% rise in the past year.
HealthEquity, carrying a Zacks Rank of 2 (Buy) at present, has an estimated long-term growth rate of 27.5%. HQY’s earnings surpassed estimates in all the trailing four quarters, with an average of 16.5%.
HealthEquity has gained 2.9% against the industry’s 7.5% decline over the past year.
Integer Holdings, flaunting a Zacks Rank of 1 at present, has an estimated long-term growth rate of 15.8%. ITGR’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 11.9%.
Integer Holdings’ shares have rallied 43.9% compared with the industry’s 4.1% rise in the past year.
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Masimo's (MASI) Stork Baby Monitoring System Approved by FDA
Masimo Corporation (MASI - Free Report) recently 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.
It is worth noting that Stork is currently available at retailers nationwide as a non-medical device for general health and wellness purposes. However, with this clearance, Stork will now be available for prescription use to continuously monitor babies at home as a medical device for healthy or sick babies.
For non-medical use, Masimo Stork bundles are available for direct consumer purchase at MasimoStork.com and on shelves at major and specialty U.S. retailers.
The latest regulatory clearance of Masimo’s home baby monitoring system is expected to significantly strengthen its remote baby monitoring business across the nation.
Significance of FDA Approval
Stork leverages the same technology that has been used on babies in the neonatal intensive care unit over the years. This is expected to help improve health outcomes for the youngest and most vulnerable patients.
Per Masimo, Stork, when prescribed, will now enable parents and family members to receive alarms regarding their baby’s oxygen saturation, pulse rate and skin temperature. They will also be likely to share these vital signs data remotely with clinicians. Stork is also expected to alert parents if their baby turns over and is sleeping face down, which can be dangerous for babies.
Per management, infant monitoring can be expensive and inconvenient due to the use of traditional hospital-grade equipment. Management believes that Stork will likely provide parents with an affordable and easy-to-use solution for monitoring their baby's health, particularly when they are unwell. This is expected to cost significantly less than traditional methods.
Industry Prospects
Per a report by Grand View Research, the global smart baby monitor market was estimated at $1,347.1 million in 2022 and is anticipated to grow at a CAGR of 7.9% between 2023 and 2030. Factors like the growing emphasis on child safety and security, the rise in the number of working families and the increasing adoption of smart home technologies are expected to drive the market.
Given the market potential, the latest FDA clearance for its smart baby monitor is likely to provide a significant boost to Masimo’s business.
Recent Developments
This month, Masimo announced the findings of a retrospective study in which researchers assessed the association between Masimo ORi (Oxygen Reserve Index) and the arterial partial pressure of oxygen in patients who underwent non-cardiac thoracic surgery during one-lung ventilation. The findings were published in the Journal of Anesthesia.
Last month, Masimo announced the receipt of the FDA’s 510(k) clearance for over-the-counter and prescription use of the Masimo W1 medical watch.
The same month, Masimo reported its third-quarter 2023 results. Per management, its healthcare business is transitioning away from COVID-era conditions. Also, management is beginning to see customer behavior and sensor purchasing patterns shifting back to the pre-pandemic growth trend line.
Price Performance
Shares of Masimo have lost 20.9% in the past year against the industry’s 4.1% rise and the S&P 500’s 24.6% growth.
Image Source: Zacks Investment Research
Zacks Rank & Stocks to Consider
Currently, Masimo carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the broader medical space are DaVita Inc. (DVA - Free Report) , DexCom, Inc. (DXCM - Free Report) and Integer Holdings Corporation (ITGR - Free Report) .
DaVita, sporting a Zacks Rank #1 (Strong Buy), has an estimated long-term growth rate of 17.3%. DVA’s earnings surpassed estimates in all the trailing four quarters, with an average surprise of 36.6%. You can see the complete list of today’s Zacks #1 Rank stocks here.
DaVita’s shares have gained 50.9% compared with the industry’s 9.7% rise in the past year.
HealthEquity, carrying a Zacks Rank of 2 (Buy) at present, has an estimated long-term growth rate of 27.5%. HQY’s earnings surpassed estimates in all the trailing four quarters, with an average of 16.5%.
HealthEquity has gained 2.9% against the industry’s 7.5% decline over the past year.
Integer Holdings, flaunting a Zacks Rank of 1 at present, has an estimated long-term growth rate of 15.8%. ITGR’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 11.9%.
Integer Holdings’ shares have rallied 43.9% compared with the industry’s 4.1% rise in the past year.