Healthcare Industry News:  Pulse Oximetry 

Devices Monitoring FDA

 News Release - August 1, 2007

Masimo Announces FDA Clearance for Additional Neonatal Parameters for Rainbow SET, Including Continuous and Noninvasive Measurement of Methemoglobin

Masimo Rainbow SET will now be available to monitor methemoglobin levels of neonatal patients undergoing inhaled nitrous oxide (iNO) therapy for hypoxic respiratory failure

IRVINE, Calif., Aug. 1 (HSMN NewsFeed) -- Masimo, the inventor of Pulse CO-Oximetry and Read-Through Motion and Low Perfusion Pulse Oximetry, today announced that it has received FDA 510(k) clearance for Pulse Oximetry (SpO2) and methemoglobin (SpMet) measurement in neonatal patients with its Rainbow adhesive sensors. The ability to continuously and noninvasively measure methemoglobin levels in neonatal patients is especially important in light of the use of inhaled nitrous oxide (iNO) therapy to treat hypoxic respiratory failure in newborns, which has been shown to induce methemoglobinemia.

According to the American Academy of Pediatrics, "infants who receive iNO therapy should be monitored according to institutionally derived protocols designed to avoid the potential toxic effects associated with iNO administration. These effects include methemoglobinemia (secondary to excess nitric oxide concentrations), direct pulmonary injury (attributable to excess levels of nitrogen dioxide), and ambient air contamination".1

Masimo Rainbow SET provides clinicians with what is believed to be the only way to continuously and noninvasively measure methemoglobin levels in the blood (SpMet), making it an appropriate technology to incorporate into neonatal iNO therapies.

With the FDA clearance of SpO2 and SpMet in neonates, more patient populations can now benefit from the noninvasive and continuous measurements that Masimo Rainbow SET can provide, including the delivery of accurate, reliable SpO2 saturation measurements from 60%-100% even during the most difficult clinical conditions of motion and low perfusion. In addition to the neonatal clearance of SpMet and SpO2, the company announced improved accuracy specifications for the noninvasive measurement of carboxyhemoglobin (SpCO) in adult, pediatric and infant patients with its Masimo Rainbow SET technology using adhesive sensors, from + 3.5% to + 3%.2

"We are happy to be able to extend the range of parameters of Masimo Rainbow SET technology available to clinicians treating neonatal patients and to be able to continue to improve the accuracy of our technology," explained Masimo Chairman and CEO Joe E. Kiani. "Attaining this clearance for SpMet in the neonatal population is the latest example of our commitment to providing enhanced levels of patient care in this critical patient population."

About Masimo

Masimo develops innovative monitoring technologies that significantly improve patient care-helping solve "unsolvable" problems. In 1995, the company debuted Read-Through Motion and Low Perfusion Pulse Oximetry, known as SET and with it substantially reduced false alarms and increased Pulse Oximetry's ability to detect life-threatening events. More than 100 independent clinical and laboratory studies have confirmed that Masimo SET technology allows clinicians to accurately monitor blood oxygen saturation in critical care situations-establishing the technology as the "gold standard" in Pulse Oximetry and substantially contributing to improved patient outcomes. In 2005, Masimo introduced Masimo Rainbow SET Pulse CO-Oximetry, which, for the first time, noninvasively monitors the level of carbon monoxide and methemoglobin in the blood, allowing early detection and treatment of potentially life-threatening conditions. Founded in 1989, Masimo has the mission of "Improving Patient Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications." Additional information about Masimo and its products may be found at http://www.masimo.com.
  1. AMERICAN ACADEMY OF PEDIATRICS: Pediatrics, Vol. 106 No. 2 August 2000, pp. 344-345, Use of Inhaled Nitric Oxide, Committee on Fetus and Newborn

  2. When used with Masimo Rainbow SET technology monitors or with licensed Masimo Rainbow SET technology modules using Rainbow series patient cables, during no motion, the accuracy of the Rainbow adhesive sensors in the range from 60% to 80% SpO2 is + 3 digits (+ 1 Std. Dev.) for adults/pediatrics/infants and 70% to 100% SpO2 is + 2 digits (+ 1 Std. Dev.) for adults/pediatrics/infants /neonates. The accuracy during motion (from 70% to 100%) is + 3 digits (+ 1 Std. Dev.) for adults/pediatrics/infants/neonates. SpO2 and SpMet accuracy was determined on 16 neonatal NICU patients ranging in age from 7 to 135 days old and weighing between 0.5 and 4.25 kgs. Seventy-nine (79) data samples were collected over a range of 70% to 100% SaO2 and 0.5 - 2.5% SbMet with a resultant accuracy of 2.9% SpO2 and 0.9% SpMet.
Masimo, SET, Signal Extraction Technology, Radical, Radical-7, Rad57, APOD, and Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications are registered trademarks of Masimo Corporation. ARM, Acoustic Respiratory Monitoring, BiFi, Rainbow, SpCO, SpMet, SpHb and Pulse CO-Oximeter are trademarks of Masimo Corporation.


Source: Masimo

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