FDA clears Masimo's noninvasive sensors for haemoglobin and oxygen
This article was originally published in Clinica
Executive Summary
The US FDA has granted 510(k) clearance for Masimo's latest family of Rainbow adhesive sensors for noninvasive monitoring of haemoglobin and oxygen. The sensors are for use with the firm's Rainbow SET-enabled devices, and can also measure oxygen saturation, pulse rate, Pleth variability index (which determines patients' fluid levels) and methaemoglobin. Irvine, California-based Masimo has also launched its noninvasive Radical-7 and Rad-87 continuous haemoglobin and oxygen monitors on a limited basis, to "selected hospitals around the world". The noninvasive test was cleared by the FDA in May (see Clinica No 1307, p 22). Previously, measuring haemoglobin involved taking a blood sample and sending it to the laboratory for testing.