NEUCHATEL, SWITZERLAND – Masimo (NASDAQ: MASI) today announced 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 (weight 3 to 30 kg). Paired with Masimo’s handheld Pronto device, the rainbow DCI-mini sensors are designed to help clinicians quickly and easily spot-check haemoglobin levels, which may facilitate the identification of anaemia — a condition reflected by low haemoglobin when there are not enough red blood cells carrying oxygen to the tissues. In low-resource countries, an estimated 3.5 billion people are anaemic,1 making it one of the world’s most common disorders.
Previously, SpHb spot-check sensors were available only for patients weighing 10 kg or more. Because iron deficient-anaemia during infancy and childhood has been shown to have long-lasting adverse effects on neurodevelopment,2 international health organizations recommend screening infants for anaemia between the ages of 9 to 12 months — an age that is often below 10 kg — with additional screening between the ages of 1 and 5 years for patients at risk.3,4
Masimo’s rainbow DCI-mini is a versatile sensor that is designed to facilitate proper placement and ease of use for clinicians and patients. The sensor 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. The new rainbow DCI-mini reusable spot-check sensor is ideal for clinics, public health programmes, and hospital emergency departments.
"The conventional process of drawing blood is a traumatic event, especially for younger patients, not to mention the cost," said Dr. Mohammed Bailony, an M.D. in paediatrics, who practices paediatric haematology-oncology at several hospitals in San Diego, including Scripps Mercy Hospital and Rady Children’s Hospital. Dr. Bailony has screened patients for anaemia in developing nations and has used the rainbow DCI-mini in clinical trials.
"SpHb assessment with the DCI-mini definitely will have a big role in developing nations, where laboratories are often not available," Dr. Bailony said. "In small cities, rural areas, and for mobile clinics, this will be a tremendous help in assessing patients. It’s fast. It’s friendly. And unlike needles, I haven’t seen a kid who’s scared of it."
"The DCI-mini allows clinicians and public health programmes around the world to expand haemoglobin assessment to vulnerable populations that need a noninvasive and convenient method," said Masimo founder and CEO Joe Kiani. "Every 90 seconds a women dies from complications due to pregnancy and many of them due to anaemia. In addition children under 5 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 DCI-mini spot-check SpHb sensor is available in Europe, Japan and many other countries, but not available for sale in the United States, Canada, China, Singapore, Brazil and Mexico. For a more detailed list of country exceptions and available markets for sale, contact Masimo Customer Service.
1 United Nations Administrative Committee on Coordination Nutrition (ACC/SCN) 4TH Report on the world nutrition situation: Nutrition Throughout the Life Cycle. Sub-Committee on Geneva: ACC/SCN; 2000.
2 Baker R, Greer R, The Committee on Nutrition, "Diagnosis and Prevention of Iron Deficiency and Iron-Deficiency Anemia in Infants and Young Children (0-3 Years of Age)" PEDIATRICS Vol. 126 No. 5 November 1, 2010 pp. 1040 -1050
3 United Nations Children’s fund, United Nations University and World Health Organization, "Iron Deficiency Anaemia, Assessment, Prevention, and Control – A Guide for Programme Managers" 2001: WHO/NHD/01.3. Available here
4 Kohli-Kumar M, "Screening for Anemia in Children: AAP Recommendations–A Critique" PEDIATRICS Vol. 108 No. 3 September 1, 2001 pp. e56
Press release via Marketwired.
