Masimo MightySat Rx Pulse Oximeter Gets FDA Clearance to Measure Breathing Rate from Fingertip

Masimo MightySatRx FDA clearance
Image: Masimo

Masimo has been granted FDA clearance for its MightySat Rx fingertip pulse oximeter to be used to spot check the respiration rate. The addition of RRp to MightySat Rx, which also measures functional oxygen saturation (SpO2), pulse rate (PR), perfusion index (Pi), and Pleth Variability Index (PVi®), makes it a more thorough and versatile spot-check solution.

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These days counting respiration rate, or the number of breaths taken per minute, is still done manually with a timer. With RRp, respiration rate can conveniently be measured using the same optical sensor that measures SpO2, PR, Pi, and PVi. RRp is provided only when the respiratory movement-induced signal is present in the pulsatile waveform and may not be available during certain conditions, such as very irregular breathing and excessive movement, reports MedGadget.

The RRp will now allow clinicians in the U.S. to measure breathing rate in various ways. RRp on MightySat Rx offers a convenient, fast, and portable option, adding to the portfolio of respiratory solutions from Masimo that includes continuous, acoustic respiration rate monitoring using RRa® and capnography-based solutions using NomoLine®. While it’s accurate in most patients, it’s not so for those that move a lot and people with certain conditions that produce irregular breathing.

Fingertip Pulse oximeter
Image: Masimo

Alongside 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. SET has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies, 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 U.S.

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MightySat Rx weighs less than 100 grams, including the batteries, and is durable and water resistant. The two AAA batteries last long enough to perform about 1,800 spot-checks, the results of which, including the plethysmographic waveforms, are displayed on the color screen. The readings can be easily transferred via Bluetooth to Masimo Professional Health app to provide historical trends and to share the data with other clinicians.

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Sam Draper
Sam Draper () is Online Editor at WT | Wearable Technologies specialized in the field of sports and fitness but also passionated about any new lifestyle gadget on the market. Sam can be contacted at press(at)