FDA clears respiration rate measurement for Masimo's home finger pulse oximeter

The new technology will be integrated into the connected MightSat Rx finger pulse oximeter.
By Laura Lovett
03:37 pm

This morning medical device company Masimo announced FDA clearance for the measurement of respiration rate from a photoplethysmogram (RRp), so that it may now be used on the MightSat Rx finger pulse oximeter. The latest clearance also means the technology can be used at home by patients.  

The new technology will be able to calculate a user’s respiration rate, which is the count of breaths per minute. The company is pitching the RRp monitor as an alternative to traditional respiration monitors, which are either fitted with chest leads or straps. 

The new designation will give Masimo’s MightSat Rx system another capability on top of its current functions, which include measuring functional oxygen saturation, pulse rate, perfusion index and Pleth Variability Index. At 100 grams, the system is easily portable, according to the company, and connects to an app via Bluetooth. 

Why it matters 

The company claims this latest clearance will help doctors find a patient’s respiration rate quicker and more easily than traditional system. According to the Clevand Clinic, an abnormal respiration rate can be an indicator of many conitions including pneumonia, asthma, anxiety, congestive heart failure, lung disease, use of narcotics or drug overdose. This latest designation will also open up the possibility for the technology to be used at home as well as in a clinic. 

What's the trend 

In the fall Masimo scored another FDA clearance, that time for its acoustic respiration sensor, the RAS-45, to be used with infants and neonatal patients as part of the Rainbow Acoustic Monitoring system. 

More recently, the company was in the news this month when it announced the US launch of its Iris Device Management System, which connects and automates Masimo devices within the hospital. The new system includes a dashboard for users to view diagnostic information about each connected device. 

More regional news


The latest news in digital health delivered daily to your inbox.

Thank you for subscribing!
Error! Something went wrong!