FDA Clears First Pulse Oximeter to Measure Breathing Rate

Masimo
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Masimo just received the first FDA clearance for a fingertip pulse oximeter that can measure respiration rate.

The MightySat Rx spot-check pulse oximeter includes a technology known as Respiration Rate from the Pleth (RRP) that makes it unnecessary to perform manual counts or use chest electrodes to measure respiration rate.

The device can be used in the clinic, but is now also indicated for at-home use. In addition to respiration rate, it measures oxygen saturation, pulse rate, perfusion index, and Masimo’s Pleth Variability Index (PVi). It also features the company’s well-known Measure-through Motion and Low Perfusion SET capabilities that continue to provide accurate data in challenging patients and conditions.

The MightySat weighs about 100 grams, including two AAA batteries that power it, and it can perform about 1,800 spot checks using those two batteries before they need to be changed. It has Bluetooth connectivity to allow for easy tracking and sharing of readings.

Masimo does note that the RRp measure may not be appropriate for some patients, as the movement-induced signal has to be detectable in the pulsatile waveform and irregular breathing can cause irregularities in measurements.

FDA Clears First Pulse Oximeter to Measure Breathing Rate