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Masimo Obtains FDA Clearance For Masimo Rainbow Set Acoustic Respiration Rate Monitoring

To detect upper airway acoustic vibrations on the surface of the skin during the respiratory cycle

Masimo has received FDA clearance for Masimo Rainbow Set Acoustic Monitoring. The company claims that Masimo Rainbow Set Acoustic Monitoring noninvasively and continuously measures respiration rate (RRa) using an adhesive sensor with an integrated acoustic transducer that is easily and comfortably applied to the patient’s neck to detect upper airway acoustic vibrations on the surface of the skin during the respiratory cycle.

Masimo Rainbow Set Acoustic Monitoring may enable earlier detection of respiratory compromise and patient distress, offering a breakthrough in patient safety for post-surgical patients on the general floor. The limited market release, which will begin in December, will allow select hospitals to be the first to benefit from the new technology.

The company said that when Masimo Rainbow Set Acoustic Monitoring is used in conjunction with Masimo Rainbow Set Pulse Co-Oximetry and the Masimo Patient SafetyNet Remote Monitoring and Clinician Notification System, clinicians can follow key indicators of oxygenation with Masimo gold standard SpO2, ventilation with RRa, circulation with Masimo measure through motion pulse rate (PR), and bleeding with Masimo noninvasive and continuous hemoglobin (SpHb) enabling them to monitor more patients, more safely, than ever before.

Joe Kiani, founder and CEO of Masimo, said: “Solving unsolvable problems that have plagued patient monitoring is key to advancing medicine and improving patient care. Masimo Rainbow Set Acoustic Monitoring addresses a longstanding and growing need to accurately and easily monitor patient breathing, which is expected to improve patient safety and decrease the cost of care in hospitals.

“It also adds another compelling reason for hospitals to choose the Masimo Rainbow Set upgradeable platform for pulse oximetry, Pulse Co-Oximetry, and now Acoustic Monitoring.”