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Masimo (MASI) Gets De Novo for Novel Oxygen Status Index ORi
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Masimo (MASI - Free Report) announced that the FDA has granted De Novo status to its noninvasive, continuous parameter — ORi (Oxygen Reserve Index) — designed to provide additional insight into a patient’s oxygen status.
ORi is the first and only FDA-cleared non-invasive and continuous parameter to provide insight into the oxygen reserve of patients, in the moderate hyperoxic range of surgical patients aged 18 and above, receiving supplemental oxygen. It is intended to help clinicians manage hyperoxia and prevent hypoxia.
The parameter is designed for use in conjunction with oxygen saturation (SpO2) enabled by the multi-wavelength Masimo rainbow Pulse CO-Oximetry platform. ORi is already available for clinicians outside the United States.
The latest regulatory clearance is expected to significantly strengthen Masimo’s patient monitoring business on a global scale.
Price Performance
Shares of Masimo have lost 47.7% year to date compared with the industry’s 10.9% decline. The S&P 500 has risen 14% in the same time frame.
Image Source: Zacks Investment Research
Significance of ORi
The De Novo status for ORi should help in better management of hyperoxia, which can lead to oxygen toxicity, causing oxygen poisoning or pulmonary tissue damage.
ORi is trended continuously with SpO2 as a unit-less index between 0.00 and 1.00 to extend the visibility of patients’ oxygenation beyond SpO2 under supplemental oxygen. By convention, SpO2 is limited to an upper limit of 100%, but oxygenation can rise into hyperoxia when supplemental oxygen is administered.
Currently, clinicians draw blood to determine PaO2 levels, the partial pressure of oxygen with the help of arterial blood gas devices. However, arterial blood analyses provide intermittent and delayed data that are unable to provide changes in oxygenation occurring between blood draw results that may lead to complications.
ORi will help overcome the shortcomings of blood draw analysis with continuous insight into the oxygenation of hemoglobin in the moderate hyperoxic range ((PaO2 > 100 and ≤ 250 mmHg). It will complement the Masimo SET pulse oximetry with additional visibility into oxygen status in real-time.
Several clinical studies have demonstrated the effectivity of the ORi parameter, which acted as a leading indicator of falling PaO2 levels when SpO2 is still greater than 98%. Data from one study showed that the use of ORi monitoring to titrate oxygen rates reduced time spent with hyperoxia compared with the use of SpO2 alone.
Masimo has introduced a new sensor line with four levels of capability. While the RD SET features only SET pulse oximetry, the rest of the sensor line — RD rainbow 4λ, RD rainbow 8λ and RD rainbow 12λ — includes the ORi parameter along with other measurements.
The continuous analysis of oxygen level and non-invasive nature of ORi should lead to strong adoption among clinicians.
Notable Developments
Earlier this month, Masimo received the CE mark for its LiDCO board-in-cable module — another parameter as a measure of continuous oxygen delivery. The use of LiDCO has been shown to reduce postoperative complications, costs and mortalities at 30 and 180 days after surgery in clinical studies.
Masimo signed a multi-year agreement with Franciscan Missionaries of Our Lady Health System (“FMOLHS”) in August. The agreement aims to implement Masimo’s monitoring technologies across FMOLHS’ systems.
The same month, Masimo announced the full U.S. market release of the Stork smart home baby monitoring system.
ALGN’s earnings surpassed estimates in two of the trailing four quarters and missed twice, delivering an average negative surprise of 1.76%. The company’s shares have risen 35% year to date compared with the industry’s 38% growth.
McKesson, carrying a Zacks Rank #2 at present, has an estimated long-term growth rate of 10.7%. MCK’s earnings surpassed estimates in three of the trailing four quarters and missed once, delivering an average surprise of 8.1%.
The stock has gained 18.7% year to date compared with the industry’s 38% growth.
Medpace, carrying a Zacks Rank #2 at present, has an estimated growth rate of 16.2% for 2024. MEDP’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 22.28%.
The company’s shares have rallied 15.9% year to date against the industry’s 12.5% decline.
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Masimo (MASI) Gets De Novo for Novel Oxygen Status Index ORi
Masimo (MASI - Free Report) announced that the FDA has granted De Novo status to its noninvasive, continuous parameter — ORi (Oxygen Reserve Index) — designed to provide additional insight into a patient’s oxygen status.
ORi is the first and only FDA-cleared non-invasive and continuous parameter to provide insight into the oxygen reserve of patients, in the moderate hyperoxic range of surgical patients aged 18 and above, receiving supplemental oxygen. It is intended to help clinicians manage hyperoxia and prevent hypoxia.
The parameter is designed for use in conjunction with oxygen saturation (SpO2) enabled by the multi-wavelength Masimo rainbow Pulse CO-Oximetry platform. ORi is already available for clinicians outside the United States.
The latest regulatory clearance is expected to significantly strengthen Masimo’s patient monitoring business on a global scale.
Price Performance
Shares of Masimo have lost 47.7% year to date compared with the industry’s 10.9% decline. The S&P 500 has risen 14% in the same time frame.
Image Source: Zacks Investment Research
Significance of ORi
The De Novo status for ORi should help in better management of hyperoxia, which can lead to oxygen toxicity, causing oxygen poisoning or pulmonary tissue damage.
ORi is trended continuously with SpO2 as a unit-less index between 0.00 and 1.00 to extend the visibility of patients’ oxygenation beyond SpO2 under supplemental oxygen. By convention, SpO2 is limited to an upper limit of 100%, but oxygenation can rise into hyperoxia when supplemental oxygen is administered.
Currently, clinicians draw blood to determine PaO2 levels, the partial pressure of oxygen with the help of arterial blood gas devices. However, arterial blood analyses provide intermittent and delayed data that are unable to provide changes in oxygenation occurring between blood draw results that may lead to complications.
ORi will help overcome the shortcomings of blood draw analysis with continuous insight into the oxygenation of hemoglobin in the moderate hyperoxic range ((PaO2 > 100 and ≤ 250 mmHg). It will complement the Masimo SET pulse oximetry with additional visibility into oxygen status in real-time.
Several clinical studies have demonstrated the effectivity of the ORi parameter, which acted as a leading indicator of falling PaO2 levels when SpO2 is still greater than 98%. Data from one study showed that the use of ORi monitoring to titrate oxygen rates reduced time spent with hyperoxia compared with the use of SpO2 alone.
Masimo has introduced a new sensor line with four levels of capability. While the RD SET features only SET pulse oximetry, the rest of the sensor line — RD rainbow 4λ, RD rainbow 8λ and RD rainbow 12λ — includes the ORi parameter along with other measurements.
The continuous analysis of oxygen level and non-invasive nature of ORi should lead to strong adoption among clinicians.
Notable Developments
Earlier this month, Masimo received the CE mark for its LiDCO board-in-cable module — another parameter as a measure of continuous oxygen delivery. The use of LiDCO has been shown to reduce postoperative complications, costs and mortalities at 30 and 180 days after surgery in clinical studies.
Masimo signed a multi-year agreement with Franciscan Missionaries of Our Lady Health System (“FMOLHS”) in August. The agreement aims to implement Masimo’s monitoring technologies across FMOLHS’ systems.
The same month, Masimo announced the full U.S. market release of the Stork smart home baby monitoring system.
Masimo Corporation Price
Masimo Corporation price | Masimo Corporation Quote
Zacks Rank & Stocks to Consider
Masimo currently carries a Zacks Rank #5 (Strong Sell).
Some better-ranked stocks in the broader medical space are Align Technology (ALGN - Free Report) , McKesson Corporation (MCK - Free Report) and Medpace (MEDP - Free Report) .
Align Technology, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 17.5%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
ALGN’s earnings surpassed estimates in two of the trailing four quarters and missed twice, delivering an average negative surprise of 1.76%. The company’s shares have risen 35% year to date compared with the industry’s 38% growth.
McKesson, carrying a Zacks Rank #2 at present, has an estimated long-term growth rate of 10.7%. MCK’s earnings surpassed estimates in three of the trailing four quarters and missed once, delivering an average surprise of 8.1%.
The stock has gained 18.7% year to date compared with the industry’s 38% growth.
Medpace, carrying a Zacks Rank #2 at present, has an estimated growth rate of 16.2% for 2024. MEDP’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 22.28%.
The company’s shares have rallied 15.9% year to date against the industry’s 12.5% decline.