Masimo Gets FDA Clearance For Tracking Tool In Ventilated Adult Patients

Masimo announced that the US Food and Drug Administration has cleared its pleth variability index (PVi) tracking tool to be used as a noninvasive indicator of fluid responsiveness in mechanically ventilated adult patients.

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With Masimo’s (MASI) PVi software, anesthesiologists and physicians can obtain fluid responsiveness data using the pulse oximeter probe and following the continuous readout on a monitor. PVi is an index between 0 and 100 that is calculated using a proprietary algorithm based upon the relative variability of the plethysmographic, or pleth waveform.

“We are thrilled that at long last we are able to offer clinicians and patients in the US the full benefits of PVi monitoring,” said Masimo CEO Joe Kiani. “Multiple studies have shown how this breakthrough noninvasive indicator of fluid responsiveness can help improve outcomes and reduce costs on mechanically ventilated patients – with no more equipment needed than a software upgrade with most existing Masimo SET and rainbow platforms and the existing Masimo SET sensors that so many top hospitals around the world already use for pulse oximetry.”

The Nasdaq-listed company said that the PVi technology has undergone rigorous peer-reviewed evaluation and demonstrated efficacy in determining adequacy of intravascular volume for guiding goal-directed therapy. The utility of PVi as a fluid responsiveness indicator has been demonstrated in more than 100 independent, published studies, Masimo said.

PVi measures the dynamic changes in the perfusion index that occur during the respiratory cycle. The perfusion index (PI) is the ratio of pulsing blood flow to nonpulsing blood flow in peripheral tissue.

Masimo medical devices include the cloud-based SafetyNet wearable monitoring devices. The sensors on the devices can track and alert patients to symptoms related to the Covid-19 virus. They can be used at hospitals or at home.

Shares in Masimo have surged 36% so far this year as the coronavirus pandemic has boosted the demand for its remote monitoring devices. (See MASI stock analysis on TipRanks)

Piper Sandler analyst Jason Bednar last week initiated the stock’s coverage with a Buy rating and a $250 price target, saying that Covid-19 has helped accelerate the trends of remote monitoring and leveraging data to support clinical decisions, which are two areas where Masimo has focused innovation.

Overall, Wall Street analysts have a cautiously optimistic outlook on the stock. The Moderate Buy consensus is divided between 4 Buy ratings versus 2 Hold ratings. The $249.25 average price target implies 16% upside potential to current levels.