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US clears Masimo rainbow Acoustic Monitoring sensor for pediatric use

Masimo (MASI) has received the US FDA 510(k) clearance for its rainbow Acoustic Monitoring sensor, RAS-125c Acoustic Respiration Cloth Sensor for monitoring acoustic respiration rate (RRa) in pediatric patients.

The RAS-125c Acoustic Respiration Cloth Sensor, which was previously cleared for adult use, is used to noninvasively and continuously assess breathing acoustically in both adult and pediatric patients.

Using an adhesive sensor with an integrated acoustic transducer, Masimo rainbow Acoustic Monitoring noninvasively and continuously measures respiration rate.

The RAS-125c Acoustic Respiration Rate Sensor is applied to the patient’s neck and its accuracy remains the same (as the adult version) at ±1 over the range of 4 to 70 breaths per minute.

Masimo founder and CEO Joe Kiani said the company has been eager to offer the patient-friendly respiration rate monitoring solution to pediatric patients in the US.

"We believe that noninvasive, continuous monitoring of acoustic respiration rate is better suited for younger patients than traditional capnography technologies that we also offer," Kiani added.

"And because the RAS-125c Acoustic Respiration Rate Sensor is more comfortable and tolerable for patients, it will help clinicians improve patient outcomes."