Articles Posted in FDA

new-brestmilk-device-300x200As matured human beings, we generally have a plethora of options when it comes to where we receive our nutrients, but for those in the fragile first 12 months of life, the choices are severely limited. Basically, the choices come down to either the less nutrient sufficient formula, or the more nutrient complex breast milk. So those who desire a more nutrient-rich diet for their infant will generally have to choose breast milk.

Recently the U.S. Food and Drug Administration permitted marketing of the Miris Human Milk Analyzer after reviewing it through the De Novo premarket review pathway, a regulatory pathway for new low-to-moderate-risk devices. This device and diagnostic test is designed to examine breast milk in order to accurately measure its nutrient composition. Breast milk composition will often vary depending on the individual, and so a test which can examine their nutritional value can be a valuable guide. The findings from this test can include concentrations of fat, carbohydrate, protein, total solids, and energy; providing healthcare professionals and parents of newborns with vital information.

The Miris Human Milk Analyzer is a prescription device used by professionals that operates by analyzing samples of human milk through an infrared spectroscopy system. This system will produce quantitative measurements of the contents contained in the milk. There are conditions that limit the information taken by the machine though, such as an interference from medication that is generally used by nursing mothers.