Masimo has secured clearance from the the US Food and Drug Administration (FDA) for the measurement of respiration rate from a photoplethysmogram (RRp), which can now be used on the MightSat Rx finger pulse oximeter.
The FDA approved the measurement of respiration rate from the pleth (RRp) on the MightySat Rx spot-check fingertip pulse oximeter, as well as its indication for use in the home environment.
Masimo MightySat Rx, which now also indicated for use at home, is claimed to be the first fingertip pulse oximeter with SET and the first to measure respiration rate.
The latest approval also means the technology can be used at home by patients.
The spot-check solution incorporates RRp to MightySat Rx, which also measures functional oxygen saturation (SpO2), pulse rate (PR), perfusion index (Pi), and Pleth Variability Index (PVi).
Traditionally, measuring respiration rate requires manually counting breaths with a timer and converting to a rate per minute, or being fitted with chest leads or straps that could be inconvenient.
With RRp, respiration rate can conveniently be measured using the same optical sensor that measures SpO2, PR, Pi, and PVi.
RRp is delivered only when the respiratory movement-induced signal is present in the pulsatile waveform and may not be available during conditions like very irregular breathing and excessive movement.
Masimo claims that through introducing RRp to the US, it facilitates clinicians to accurately measure breathing rate, and to ensure they have the right tools for each patient scenario. RRp on MightySat Rx adds to the portfolio of respiratory solutions from Masimo and offers a convenient, fast, and portable option.
The company’s portfolio also includes continuous, acoustic respiration rate monitoring using RRa and capnography-based solutions using NomoLine.
Along with RRp, PVi, PR, and Pi, MightySat Rx features the same Measure-through Motion and Low Perfusion SET pulse oximetry available in a variety of bedside Masimo and OEM monitors.
The company says that the SET has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies. It is estimated to be used on more than 100 million patients a year, and is the primary pulse oximetry at 9 of the top 10 hospitals listed in the 2018-19 US News and World Report Best Hospitals Honor Roll.
MightySat Rx is designed to be small and light, weighing less than 100 grams with batteries, but also durable and long-lasting, with an IP23 ingress rating and providing approximately 1,800 spot-checks with each set of 2 AAA batteries.
The product is available in both black and white, offering high-resolution color display, including display of plethysmographic waveforms, along with a Bluetooth wireless interface to the Masimo Professional Health mobile application to track, trend, and communicate measurements.