FDA clears Masimo device for ventilated patients

Masimo (NSDQ:MASI) announced today that it received FDA clearance for its PVi for fluid responsiveness indication in ventilated adult patients.
PVi (pleth variability index) now has indication as a continuous, non-invasive, dynamic indicator of responsiveness in select populations of mechanically ventilated adult patients, as it measures dynamic changes in the perfusion index that occur during the respiratory cycle, according to a news release.
Irvine, Calif.-based Masimo’s PVi is available alongside its SET pulse oximetry and Rainbow pulse co-ocimetry on a variety of sensors, using a proprietary algorithm based on the relative variability of the pleth waveform.
In an 18,716-patient study in France, researchers found that using PVi alongside Masimo’s SpHb continuous hemoglobin monitoring technology led to earlier transfusion and fewer units of blood transfused, as well as a 33% lower mortality rate 30 days after surgery, which trickled down to a 29% rate 90 days after surgery.
“We are thrilled that at long last we are able to offer clinicians and patients in the U.S. the full benefits of PVi monitoring,” Masimo founder & CEO Joe Kiani said in the release. “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.”
Original Article: (https://www.massdevice.com/fda-clears-masimo-device-for-ventilated-patients/)