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US FDA Grants Clearance To Masimo’s New Rainbow Resposable Sensor System

Masimo announced the FDA 510(k) clearance of its new Masimo Rainbow Resposable Sensor System, a new sensor system that offers the performance and comfort of a single-use adhesive disposable sensor with environmentally-green advantages of a reusable sensor. The new sensor system provides continuous and noninvasive measurements of hemoglobin (SpHb), oxygen content (SpOC), PVI for fluid responsiveness, and methemoglobin (SpMet), in addition to oxygen saturation (SpO2), perfusion index, and pulse rate at savings of about 50% compared to the existing single patient use adhesive Rainbow sensor.

The Rainbow Resposable Sensor System combines the best features of Masimo LNOP, LNCS, and Rainbow sensors into an innovative two-piece design that includes a reusable sensor enabling the portion that connects to the patient cable to be used on multiple patients while the adhesive disposable sensor that attaches directly to the patient’s finger is used on only one patient. This dramatically minimizes waste, enabling hospitals to reduce their costs safely, and effectively fulfill their ‘green’ initiatives.

The reusable portion of the two-piece system provides multi-patient use for cost-effectiveness, while the flexible cable design maximizes patient comfort, and enables easy, one-step cleaning. The snap-in-place connector design allows easy connection and reconnection to the same patient and reuse on the next patient. The single-use disposable portion of system features an adhesive that keeps emitter and detector positions stable against the skin to assure the best in Masimo SET and Rainbow SET measurement performance. The design maximizes fit and comfort for the patient, while the protective covering minimizes contact with patient to reduce cross contamination risk.

We have tried the Masimo Rainbow Resposable System and found that these sensors provided us with all of the benefits and superior performance of Masimo’s continuous and noninvasive Rainbow measurements, including noninvasive hemoglobin monitoring, along with the cleanliness and patient comforts of the standard single patient use sensor at a fraction of the cost and waste, stated Bertrand Debaene, M.D., Department of Anesthesia at the University Hospital Center in Poitiers, France.

The Masimo Rainbow Resposable Sensor System is based on more than ten years of research and development stemming from the feedback of hundreds of clinicians who told us what they wanted most in a sensor less waste and more value with superior performance, stated Masimo Founder and CEO, Joe E. Kiani. We are happy that by combining the performance and patient comfort of a single-use adhesive sensor with the cost effectiveness of a reusable sensor, the Masimo Rainbow Resposable Sensor System also minimizes medical waste and its impact on the environment.