California-based medical device maker Masimo (NSDQ:MASI) is planning a limited market launch of its 1st-of-its kind hemoglobin monitor for infants and small children after winning approval from regulators in Japan and Europe.
Masimo’s new rainbow DCI-mini works with the company’s Pronto handheld system and is designed for easy, non-invasive spot-checks of hemoglobin levels in infants and kids from 3kg to 30 kg (about 7lb-66lb). Low hemoglobin levels are often associated with signs of anemia, one of the most common disorders worldwide.
The rainbow DCI-mini is the 1st sensor of its kind approved for patients weighing less than 10kg (22lb), Masimo said. Other marketed sensors are indicated for larger patients, but global health groups recommend anemia-screening for infants from the age of 9 to 12 months and for kids from the age of 1 to 5 years.
Conventional blood-based tests are more difficult for children and come with greater costs, hematology-oncology pediatrician Dr. Mohammed Bailony said on behalf of the company.
"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 prepared remarks. "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 is not yet cleared for use in the U.S.
