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Masimo's (MASI) Rad-G Pulse Oximeter Receives FDA Clearance
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Masimo Corporation (MASI - Free Report) recently received FDA clearance of the Rad-G Pulse Oximeter — a rugged handheld device — offering clinically proven Signal Extraction Technology (SET) pulse oximetry, respiration rate from the pleth (RRp) and other crucial parameters for spot-checking and continuous monitoring. This will help clinicians to evaluate patients quickly and arrive at informed care decisions where pulse oximetry or vital signs checking is required in a compact, portable form factor.
This regulatory clearance will provide a boost to Masimo’s SET pulse oximeter solution.
Masimo Rad-G Pulse Oximeter at a Glance
The new multipurpose, direct-connect Rad-G sensor can be utilized to monitor both adult and pediatric patients. The Rad-G sensor further enhances Rad-G’s versatility and ease of use, without requiring to stock and carry multiple sensor types, particularly in far more challenging field environments.
Apart from this, Rad-G is compatible with Masimo’s wide portfolio of reusable and single-patient use sensors, thereby boosting its flexibility and enabling clinicians to customize the solution on the basis of the unique requirements of each care setting.
Significance of the Approval
It is important to mention here that difficulty in breathing is acknowledged to be one of the earliest signs of patient deterioration. With the availability of RRp on Rad-G, Masimo is optimistic that it will aid clinicians and public health officials to fight respiratory-related illnesses, which includes pneumonia and COVID-19.
It has become crucial for caregivers to have access to the most accurate and reliable pulse oximetry monitoring technologies amid the ongoing pandemic.
Market Prospects
Per a report by Grand View Research, the global remote patient-monitoring system market is anticipated to reach $1.8 billion by 2026 from 2019, at a CAGR of 13.5%. Hence, this regulatory clearance is well-timed.
Recent Development
In September, Masimo announced that its O3 Regional Oximetry has received FDA approval for expanded use in monitoring somatic tissue oxygenation saturation in all patient population and assessing relative changes in hemoglobin, oxyhemoglobin, and deoxyhemoglobin in adult brains. With this FDA approval, O3 is now cleared for use in both cerebral and somatic applications, in the United States and other countries, with respect to all patient population.
Last month, Hologic, Inc. (HOLX - Free Report) received the FDA’s Emergency Use Authorization (EUA) for its Panther Fusion SARS-CoV-2 assay. The assay will be used to test asymptomatic (without symptoms) individuals and those having symptoms of the COVID-19 infection. Additionally, the FDA has authorized Hologic’s pooling protocol, which was announced on Aug 11, for symptomatic testing with the Panther Fusion SARS-CoV-2 assay.
Moreover, in the same month, Abbott Laboratories (ABT - Free Report) received the CE Mark for its fourth-generation MitraClip Transcatheter Mitral Valve Repair (TMVR) System — MitraClip G4. It is a renowned minimally invasive mitral valve repair device, which is already approved for use in the United States.
That’s not all. Recently, Medtronic plc’s (MDT - Free Report) TYRX Absorbable Antibacterial Driveline Wrap gained Breakthrough Device Designation. This designation ensures that patients will gain timely access to this product, which is considered to have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating cardiovascular disease, by speeding up all relevant regulatory procedures.
These Stocks Are Poised to Soar Past the Pandemic
The COVID-19 outbreak has shifted consumer behavior dramatically, and a handful of high-tech companies have stepped up to keep America running. Right now, investors in these companies have a shot at serious profits. For example, Zoom jumped 108.5% in less than 4 months while most other stocks were sinking.
Our research shows that 5 cutting-edge stocks could skyrocket from the exponential increase in demand for “stay at home” technologies. This could be one of the biggest buying opportunities of this decade, especially for those who get in early.
Image: Bigstock
Masimo's (MASI) Rad-G Pulse Oximeter Receives FDA Clearance
Masimo Corporation (MASI - Free Report) recently received FDA clearance of the Rad-G Pulse Oximeter — a rugged handheld device — offering clinically proven Signal Extraction Technology (SET) pulse oximetry, respiration rate from the pleth (RRp) and other crucial parameters for spot-checking and continuous monitoring. This will help clinicians to evaluate patients quickly and arrive at informed care decisions where pulse oximetry or vital signs checking is required in a compact, portable form factor.
This regulatory clearance will provide a boost to Masimo’s SET pulse oximeter solution.
Masimo Rad-G Pulse Oximeter at a Glance
The new multipurpose, direct-connect Rad-G sensor can be utilized to monitor both adult and pediatric patients. The Rad-G sensor further enhances Rad-G’s versatility and ease of use, without requiring to stock and carry multiple sensor types, particularly in far more challenging field environments.
Apart from this, Rad-G is compatible with Masimo’s wide portfolio of reusable and single-patient use sensors, thereby boosting its flexibility and enabling clinicians to customize the solution on the basis of the unique requirements of each care setting.
Significance of the Approval
It is important to mention here that difficulty in breathing is acknowledged to be one of the earliest signs of patient deterioration. With the availability of RRp on Rad-G, Masimo is optimistic that it will aid clinicians and public health officials to fight respiratory-related illnesses, which includes pneumonia and COVID-19.
It has become crucial for caregivers to have access to the most accurate and reliable pulse oximetry monitoring technologies amid the ongoing pandemic.
Market Prospects
Per a report by Grand View Research, the global remote patient-monitoring system market is anticipated to reach $1.8 billion by 2026 from 2019, at a CAGR of 13.5%. Hence, this regulatory clearance is well-timed.
Recent Development
In September, Masimo announced that its O3 Regional Oximetry has received FDA approval for expanded use in monitoring somatic tissue oxygenation saturation in all patient population and assessing relative changes in hemoglobin, oxyhemoglobin, and deoxyhemoglobin in adult brains. With this FDA approval, O3 is now cleared for use in both cerebral and somatic applications, in the United States and other countries, with respect to all patient population.
Last month, Hologic, Inc. (HOLX - Free Report) received the FDA’s Emergency Use Authorization (EUA) for its Panther Fusion SARS-CoV-2 assay. The assay will be used to test asymptomatic (without symptoms) individuals and those having symptoms of the COVID-19 infection. Additionally, the FDA has authorized Hologic’s pooling protocol, which was announced on Aug 11, for symptomatic testing with the Panther Fusion SARS-CoV-2 assay.
Moreover, in the same month, Abbott Laboratories (ABT - Free Report) received the CE Mark for its fourth-generation MitraClip Transcatheter Mitral Valve Repair (TMVR) System — MitraClip G4. It is a renowned minimally invasive mitral valve repair device, which is already approved for use in the United States.
That’s not all. Recently, Medtronic plc’s (MDT - Free Report) TYRX Absorbable Antibacterial Driveline Wrap gained Breakthrough Device Designation. This designation ensures that patients will gain timely access to this product, which is considered to have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating cardiovascular disease, by speeding up all relevant regulatory procedures.
These Stocks Are Poised to Soar Past the Pandemic
The COVID-19 outbreak has shifted consumer behavior dramatically, and a handful of high-tech companies have stepped up to keep America running. Right now, investors in these companies have a shot at serious profits. For example, Zoom jumped 108.5% in less than 4 months while most other stocks were sinking.
Our research shows that 5 cutting-edge stocks could skyrocket from the exponential increase in demand for “stay at home” technologies. This could be one of the biggest buying opportunities of this decade, especially for those who get in early.
See the 5 high-tech stocks now>>