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Masimo O3 Regional Oximetry Device Gets FDA 510 (k) Nod
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Masimo Corporation (MASI - Free Report) recently announced the receipt of FDA 510 (k) approval for the O3 regional oximetry device. The approval will allow the company to market the device in the U.S.
Per Masimo, “Regional oximetry, also referred to as tissue or cerebral oximetry, may help clinicians monitor cerebral oxygenation in situations in which pulse oximetry alone may not be fully indicative of the oxygen in the brain.”
O3 regional oximetry uses near-infrared spectroscopy (NIRS) to continuously monitor absolute and trended regional tissue oxygen saturation in the cerebral region. Clinical studies have found that when compared with data obtained from blood samples through induced hypoxia, O3 provided absolute root-mean-squared error of 4% and relative root-mean-squared error of 2.1%.
The addition of O3 to Masimo’s Root platform will enable clinicians to simultaneously access a number of monitoring technologies including rSO2. The other devices are SedLine Brain Function monitoring, Masimo (Signal Extraction Technology) SET SpO2, PVI and SpHb monitoring.
Most recently, Masimo launched Pronto Pulse CO-Oximeter, its next-generation SpHb Spot Check technology, for markets outside the U.S. The company also unveiled its next-generation SedLine Brain Function monitoring technology at the European Society of Anaesthesiology’s (ESA) 2016 Euroanaesthesia Congress in London, England.
Meanwhile, Masimo continues to win new customers outside the U.S. India-based Motherhood Hospitals recently selected Masimo SET pulse oximetry at all the three locations it operates in. The hospital also selected Masimo’s technology for screening Critical Congenital Heart Disease (CCHD).
We believe Masimo’s innovative product portfolio is a key catalyst. Moreover, wider adoption of non-invasive patient monitoring technology will help the company gain market traction. The company’s SET pulse oximetry business represents considerable growth opportunities in international markets.
Zacks Rank & Other Key Picks
Masimo sports a Zacks Rank #1 (Strong Buy)
Other well-placed stocks in the medical space are CryoLife , IRadimed (IRMD - Free Report) and Halyard Health . All the three stocks sport a Zacks Rank #1.
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Masimo O3 Regional Oximetry Device Gets FDA 510 (k) Nod
Masimo Corporation (MASI - Free Report) recently announced the receipt of FDA 510 (k) approval for the O3 regional oximetry device. The approval will allow the company to market the device in the U.S.
Per Masimo, “Regional oximetry, also referred to as tissue or cerebral oximetry, may help clinicians monitor cerebral oxygenation in situations in which pulse oximetry alone may not be fully indicative of the oxygen in the brain.”
O3 regional oximetry uses near-infrared spectroscopy (NIRS) to continuously monitor absolute and trended regional tissue oxygen saturation in the cerebral region. Clinical studies have found that when compared with data obtained from blood samples through induced hypoxia, O3 provided absolute root-mean-squared error of 4% and relative root-mean-squared error of 2.1%.
The addition of O3 to Masimo’s Root platform will enable clinicians to simultaneously access a number of monitoring technologies including rSO2. The other devices are SedLine Brain Function monitoring, Masimo (Signal Extraction Technology) SET SpO2, PVI and SpHb monitoring.
Most recently, Masimo launched Pronto Pulse CO-Oximeter, its next-generation SpHb Spot Check technology, for markets outside the U.S. The company also unveiled its next-generation SedLine Brain Function monitoring technology at the European Society of Anaesthesiology’s (ESA) 2016 Euroanaesthesia Congress in London, England.
Meanwhile, Masimo continues to win new customers outside the U.S. India-based Motherhood Hospitals recently selected Masimo SET pulse oximetry at all the three locations it operates in. The hospital also selected Masimo’s technology for screening Critical Congenital Heart Disease (CCHD).
MASIMO CORP Revenue (TTM)
MASIMO CORP Revenue (TTM) | MASIMO CORP Quote
We believe Masimo’s innovative product portfolio is a key catalyst. Moreover, wider adoption of non-invasive patient monitoring technology will help the company gain market traction. The company’s SET pulse oximetry business represents considerable growth opportunities in international markets.
Zacks Rank & Other Key Picks
Masimo sports a Zacks Rank #1 (Strong Buy)
Other well-placed stocks in the medical space are CryoLife , IRadimed (IRMD - Free Report) and Halyard Health . All the three stocks sport a Zacks Rank #1.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>