Masimo gets CE Mark clearance in Japan for rainbow DCI-mini sensors

31 August 2014 (Last Updated August 31st, 2014 18:30)

US-based non-invasive patient monitoring technologies manufacturer Masimo has received CE Mark clearance in Japan and limited market release of the rainbow DCI-mini, the first noninvasive haemoglobin (SpHb) spot-check sensor for infants and small children.

US-based non-invasive patient monitoring technologies manufacturer Masimo has received CE Mark clearance in Japan and limited market release of the rainbow DCI-mini, the first noninvasive haemoglobin (SpHb) spot-check sensor for infants and small children.

The rainbow DCI-mini sensors paired with the company's handheld Pronto device helps clinicians quickly and easily spot-check haemoglobin levels for children weighing 3kg-30kg

Spot checking of haemoglobin levels will help in the identification of anaemia, a condition reflected by low haemoglobin when there are not enough red blood cells carrying oxygen to the tissues.

The SpHb spot-check sensors were previously available for patients weighing 10kg or more.

"The DCI-mini allows clinicians and public health programmes around the world to expand haemoglobin assessment to vulnerable populations that need a non-invasive and convenient method."

International health organisations suggest screening infants for anaemia between the ages of nine to 12 months, because iron deficient-anaemia during infancy and childhood has shown to have long-lasting adverse effects on neurodevelopment.

Additional screening will also be carried out between the ages of one and five years for patients at risk.

The rainbow DCI-mini sensor is designed to facilitate proper placement and ease-of-use for clinicians and patients.

It uses a lightweight ribbon cable to connect to the Pronto device and a digit clip that is applied to a small child's finger or on an infant's big toe or thumb.

Masimo founder and CEO Joe Kiani said: "The DCI-mini allows clinicians and public health programmes around the world to expand haemoglobin assessment to vulnerable populations that need a non-invasive and convenient method.

"Every 90 seconds, a women dies from complications due to pregnancy and many of them due to anaemia. In addition, children under five years old who suffer from anaemia do not develop fully, which has long-term implications to the lives of those afflicted, as well as society in general.

"We hope that the new rainbow DCI-mini will help more infants and small children, along with their moms, around the globe to receive timely assessment and treatment, which will benefit their long-term health, as well as the health of our society."

The company said that the DCI-mini spot-check SpHb sensor is available in Europe, Japan and many other countries. It is not available for sale in the US, Canada, China, Singapore, Brazil and Mexico.