Masimo (NSDQ:MASI) said it has won the CE Mark for a noninvasive and continuous hemoglobin monitor for newborn and infant patients weighing less than 3 kg (6.61 lbs.).
SpHb uses the company’s Rainbow sensors, which allow clinicians to simultaneously measure multiple additional noninvasive parameters alongside SpHb, including oxygen saturation (SpO2) and methemoglobin (SpMet).
Current invasive methodologies for measuring newborns’ and infants’ hemoglobin can only provide intermittent, delayed results, according to the Irvine, Calif.-based company. By providing a continuous, noninvasive measurement, SpHb allows clinicians to more closely monitor neonatal hemoglobin status in real time by tracking the stability, or instability, of a patient’s hemoglobin trend, providing visibility into changes, or lack of changes, in hemoglobin between invasive blood samples.
“We are thrilled to be able to bring the power of noninvasive hemoglobin monitoring with SpHb to the youngest, most fragile patients of all,” said Masimo CEO Joe Kiani in a news release. “We have long been dedicated to helping improve the lives of neonatal and infant patients, and this latest clearance significantly furthers that mission. SpHb is already used to monitor adult patients in more than 75 countries. We look forward to witnessing the impact that SpHb will now be able to have on neonatal and infant patients.”
Noninvasive, continuous SpHb has received FDA clearance for patients >3 kg but is not currently indicated for patients <3 kg in the U.S.
