Masimo's MightSat Rx Finger Pulse Oximeter Gains FDA Clearance for Respiratory Rate Measurement via RRp

VCBeat (WeChat Official Account: vcbeat) has learned that on January 28, U.S. local time, medical device company Masimo announced that the U.S. Food and Drug Administration (FDA) had approved the use of photoplethysmography (RRp) for measuring respiratory rate in the healthcare industry. As a result, the Masimo MightySat Rx finger pulse oximeter can now be officially used for respiratory rate measurement. Furthermore, this approval means that patients can use this technology at home. Reportedly, the Masimo MightySat Rx is the first fingertip pulse oximeter equipped with SET® technology and the first device capable of measuring respiratory rate.

Masimo is a medical technology company that develops, manufactures, and markets noninvasive monitoring technologies worldwide. Founded in 1989 and headquartered in California, United States, the company is dedicated to improving patient outcomes and reducing the cost of care.

Masimo MightySat™ Rx with RRp (Image source: Masimo official website)

In 1995, Masimo introduced Masimo SET®, a pulse oximetry technology designed for accurate measurement during motion and low perfusion. This method has been demonstrated in numerous studies to significantly reduce false alarms while accurately monitoring true alerts. Masimo SET® has also been shown to assist clinicians in reducing the incidence of retinopathy of prematurity (ROP) in neonates and premature infants, and to improve screening rates for congenital heart defects (CCHD) in newborns. When Masimo Patient SafetyNet™ is used for continuous monitoring in postoperative wards, it helps reduce the response time to rapid deterioration events. Statistics show that Masimo SET® is utilized by leading hospitals and other healthcare institutions worldwide, benefiting over 100 million patients. Among the top 10 best hospitals listed in the 2018–2019 U.S. News & World Report rankings, nine adopted Masimo SET® as their primary pulse oximetry technology.

Respiratory rate, or breaths per minute, typically requires manual counting with a timer and subsequent conversion to a per-minute rate. Furthermore, traditional respiratory monitors are mostly equipped with chest leads or chest belts, which significantly cause inconvenience in use. The use of RRp enables the same optical sensors that measure SpO2, PR, PI, and PVi to conveniently measure respiratory rate. RRp is provided only when respiration-induced signals are present in the pulsatile waveform, and it may be unavailable in certain situations (e.g., highly irregular breathing and excessive motion).

The MightySat RX is compact, lightweight (under 100 grams with battery), and durable, with an IP23 ingress protection rating (protected against water spray at angles up to 60 degrees from vertical). Each set of two AAA batteries provides approximately 1,800 spot checks. The MightySat RX features a high-resolution color display available in black or white, including plethysmograph waveform display, and a Bluetooth wireless interface for connectivity with the Masimo Professional Health mobile app to track, monitor trends, and share measurement results.

With the introduction of RRp to the United States, Masimo now provides clinicians with a more accurate method for measuring respiratory rate than ever before, helping to ensure they can deliver appropriate tools tailored to each patient’s condition. The RRp feature on the MightySat Rx offers a convenient, rapid, and portable option, enhancing the selectivity of Masimo’s respiratory solutions portfolio, which includes continuous acoustic respiratory rate monitoring using RRA and capnography-based solutions using NomoLine.

(Compiled by Yang Fudong)