MightySat Rx Cleared by FDA to Measure Breathing Rate from Fingertip

Masimo won FDA clearance for its MightySat Rx fingertip pulse oximeter to be used to spot check the respiration rate. A similar clearance was issued by the European Union regulatory authorities in 2017. These days the breathing rate is still counted manually more often than not. Though there are devices in existence, even contact-free ones, that can measure the breathing rate, they tend to be pricey, designed for bedridden patients, and they can’t be properly used in a variety of settings.

The MightySat Rx uses the company’s Respiration Rate from the Pleth (RRp) technology to measure a patient’s breathing, and also provides oxygen saturation (SpO2), pulse rate, perfusion index, and Pleth Variability Index (PVi). RRP notices how the respiratory cycle changes the nature of the pulses detected by the oximeter. 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.

The device weighs less than 100 grams, including the batteries, and is water resistant. The two AAA batteries provide enough juice 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.