When we wrote about technology and human breast milk previously, the focus was wearable breast pumps from Willow and Chiaro. We also wrote about JustMilk‘s work developing a breastfeeding drug delivery system to use in remote regions where children may not receive pharmaceuticals they need.
Sweden-based Miris Solutions recently began selling the Miris Human Milk Analyzer in South Africa. The Miris HMA measures macronutrient concentrations in mothers’ milk. Miris designed the HMA as a medical instrument used to be sure premature and sick babies get the nutrients they need.
The FDA cleared the Miris HMA for marketing in the U.S. as a class III designated, “not substantially equivalent” device last December. The FDA’s approval followed a review of data submitted with the analysis of 112 human milk samples. The sample reports showed similar results to independent test analyses that measured quantitative amounts of fat, protein, total carbohydrate content, and the total solid and energy content in the milk.
The Miris HMA analyzes human milk samples with an infrared spectroscopy system. Under the FDA clearance, the Miris HMA is a prescription device for use in clinical laboratories by trained personnel.
