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Masimo PVi Gets FDA Approval to Measure Fluid Responsiveness

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Masimo Corporation (MASI - Free Report) recently announced that PVi has obtained FDA approval as a continuous, noninvasive, dynamic indicator of fluid responsiveness in select populations of mechanically-ventilated adult patients. PVi or pleth variability index is an indicator of the dynamic changes in perfusion index that take place during the respiratory cycle.

This regulatory clearance is expected to boost the company’s Signal Extraction Technology (SET) Pulse Oximetry portfolio.

More About Masimo PVi

With PVi, one can now obtain crucial data using the pulse oximeter probe and following the continuous readout on the monitor. The PVi technology has been put through meticulous peer-reviewed evaluation and it has exhibited efficiency in determining adequacy of intravascular volume for guiding goal-directed therapy. The recent approval of the system marks another major breakthrough in patient safety.

PVi is an index between 0 and 100 that is calculated using a proprietary algorithm based on the relative variability of the pleth waveform. Moreover, it is available along with Masimo SET pulse oximetry and rainbow Pulse CO-Oximetry on a variety of 2-LED, 4-LED, and 8-LED Masimo sensors.

The utility of PVi as a fluid responsiveness indicator has been highlighted in more than 100 independent, published studies, including in Goal-directed Therapy (GDT) and Enhanced Recovery After Surgery (ERAS) ERAS protocols.

Moreover, PVi has been used along with Masimo’s noninvasive, continuous hemoglobin monitoring technology (SpHb).

PVi is a highly effective tool for evaluating a patient’s fluid status. This non-invasive indicator of fluid responsiveness can help ensure enhancement of outcomes and reduction of costs on mechanically ventilated patients with no more equipment needed than a software upgrade with most existing Masimo SET and rainbow platforms.

Industry Prospects

Per a report by Grand View Research, the global pulse oximeter market size was valued at $1.8 billion in 2018 and is projected to see a CAGR of 6.3% between 2019 and 2025. Given the market potential, the FDA clearance is well-timed.

Recent Development

In March 2020, Masimo obtained FDA clearance for the continuous RRp (respiration rate from the photoplethysmograph) monitoring of adult and pediatric patients with Rad-97, Radical-7 and Radius-7 Pulse CO-Oximeters.With this go-ahead, both continuous and spot-check RRp are now commercially available in the United States. It is supported by a wide range of pulse oximetry sensors and configurations, including the new non-cabled, tetherless, wearable Radius PPG. The FDA clearance of this monitoring system is expected to strengthen the company’s portfolio of pulse oximetry technologies.

Price Performance

In the past year, the company’s shares have outperformed the industry. The stock has rallied 40.7% compared with the industry’s 21.6% growth.

Zacks Rank and Key Picks

Masimo currently carries a Zacks Rank #5 (Strong Sell).

A few better-ranked stocks from the broader medical space include OPKO Health (OPK - Free Report) , Surmodics (SRDX - Free Report)  and PerkinElmer (PKI - Free Report) .

OPKO Health’s long-term earnings growth rate is estimated at 12%. The company presently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Surmodics’ long-term earnings growth rate is estimated at 10%. The company presently carries a Zacks Rank #2.

PerkinElmer’ long-term earnings growth rate is estimated at 17.4%. It currently carries a Zacks Rank #1.

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