Masimo gains FDA clearance for new respiration rate measurement system

Masimo (NSDQ:MASI) said today that the FDA has granted 510(k) clearance to its continuous RRp (respiration rate from the photoplethysmograph) monitoring of adult and pediatric patients with Rad-97, Radical-7, and Radius-7 Pulse CO-Oximeters.
With this clearance, both continuous and spot-check RRp are now available in the U.S., supported in a variety of pulse oximetry sensors and configurations, including the new non-cabled, tetherless, wearable Radius PPG, according to the Irvine, Calif.-based company. Masimo already offers acoustic respiration rate (RRa) and and capnography (RRc) systems.
Determining respiration rate, or the number of breaths taken per minute, in many situations typically requires manually counting breaths with a timer and then converting to a rate per minute, or being fitted with chest leads or straps that can be inconvenient. RRa has been shown in some studies to be an accurate, reliable, easy-to-use and -tolerate method of monitoring respiration rate on a continuous basis, the company said in a news release. If RRa or RRc is not available for patients whose arterial oxygen saturation (SpO2) is already being monitored using Masimo SET pulse oximetry, RRp offers a convenient way to accurately obtain respiration rate.
RRp is well-suited to lower acuity settings like the general ward, where patients are less likely to have respiration rate-monitoring technologies available. In scenarios where the ability to detect respiratory pause is important, such as during surgery or recovery after surgery, RRp should not be used; RRa or RRc is more appropriate.
With breathing difficulty generally considered one of the earliest signs of patient deterioration, Masimo hopes that the availability of RRp may be able to play a role in assisting clinicians and public health officials as they seek to combat respiratory-related illnesses, including the coronavirus COVID-19, especially when applying an additional sensor is not an option.
“We aim to provide clinicians with the best monitoring tools so that they can provide the best care possible – which means recognizing that a monitoring method that works particularly well in one patient scenario may not be available or be the best choice in another,” Masimo CEO Joe Kiani said in the news release. “With the introduction of continuous RRp to our devices in the U.S., we are finally able to give clinicians in our home country a powerful third way to monitor respiration rate continuously, complementing other methods with a convenient and cost-effective single-sensor solution.”
Original Article: (https://www.massdevice.com/masimo-gains-fda-clearance-for-new-respiration-rate-measurement-system/)