News | August 01, 2007

Masimo Announces Clearance for Neonatal Parameters

August 2, 2007 — Masimo 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.
Masimo Rainbow SET provides clinicians with a way to continuously and noninvasively measure methemoglobin levels in the blood (SpMet).

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, according to the manufacturer.

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

For more information:

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