Masimo announces CE marking of neonatal indication for non-invasive, continuous haemoglobin monitoring

Masimo has received CE marking of SpHb non-invasive and continuous haemoglobin monitoring for neonatal and infant patients less than three kilograms. With this clearance SpHb is available for patients of all ages in CE mark countries. SpHb for neonates and infants is provided on rainbow sensors, which allow clinicians to simultaneously measure multiple additional non-invasive parameters alongside SpHb, including oxygen saturation and methaemoglobin.

Current invasive methodologies for measuring haemoglobin can only provide intermittent, delayed results. By providing a continuous, non-invasive measurement, SpHb allows clinicians to more closely monitor neonatal haemoglobin status in real-time by tracking the stability or instability of a patient's haemoglobin trend, providing visibility into changes or lack of changes in haemoglobin between invasive blood samples.

SpHb is not intended to replace laboratory blood testing.