Masimo (NSDQ:MASI) said today it won CE Mark approval in the European Union for its Rainbow Super DCI-mini sensor designed as a reusable spot-check sensor with multiple physiologic measurements.
The Irvine, Calif.-based company said that the newly cleared, reusable sensor includes for the 1st time the ability to measure total hemoglobin, carboxyhemoglobin, methemoglobin and arterial oxygen saturation.
Masimo said that with the release of the Rainbow DCI-mini sensor, an expanded set of parameters can be measured with a single sensor, including SpO2, pulse rate, perfusion index, pleth variability index, SpHb, SpCO and SpMet. The sensor can be used to spot-check all patients 3 kg or more, the company added.
“This is an exciting day for us and hopefully a great opportunity to improve patient care. Since the invention of rainbow technology, we have been wanting our customers to be able to measure SpCO, SpMet, SpHb and SpO2 simultaneously. Now they can! In addition, we have been pursuing a spot-check sensor that fits all patients across the age spectrum. We believe the rainbow Super DCI-mini sensor will be especially valuable for use in triage and emergency care situations. We plan to introduce a continuous measurement version of the Super Sensor in the near future,” CEO Joe Kiani said in a press release.
The Rainbow DCI-Mini sensor has not yet received FDA 510(k) clearance in the US, the company said.
In May, Masimo said it won FDA 510(k) clearance for a pediatric indication for O3 regional oximetry with its O3 pediatric sensor.
