Senator Medical AB in Stockholm, Sweden introduces an innovative Swedish medical device with FDA Approval

Donor human milk is a standard of care in many maternity wards caring for preterm infants. While very effective, the nutritional content of donor milk is often subpar and requires targeted fortification.

Miris, based in Uppsala, Sweden, won FDA clearance for its Human Milk Analyzer, a novel device used to test donor breast milk for energy, fat, carbohydrate, and protein content. The device provides results within minutes using only a small sample of milk. The technology allows clinicians to fortify donor milk with the right ingredients before it is administered to preterm babies.

The system consists of the Miris Ultrasonic Processor and Miris Heater that are used to prepare samples, and the Miris Human Milk Analyzer for analysis.

Some details about the study that led to the clearance, according to Miris:The FDA reviewed data submitted by the sponsor of 112 samples of human milk to analyze the performance of the device. For the study, the sponsor tested the same 112 samples in the machine and compared them to the expected true values obtained by independent methods; both systems provided similar results for each test. The data showed that the Miris Human Milk Analyzer test was effective at determining levels of protein, fat and carbohydrate in the milk.

There may be conditions that limit the information available from the Miris Human Milk Analyzer. For example, certain medications that a nursing mother may be taking could interfere with the test’s ability to accurately measure nutrient levels in breast milk.

The FDA reviewed data submitted by the sponsor of 112 samples of human milk to analyze the performance of the device. For the study, the sponsor tested the same 112 samples in the machine and compared them to the expected true values obtained by independent methods; both systems provided similar results for each test. The data showed that the Miris Human Milk Analyzer test was effective at determining levels of protein, fat and carbohydrate in the milk. There may be conditions that limit the information available from the Miris Human Milk Analyzer.

For example, certain medications that a nursing mother may be taking could interfere with the test’s ability to accurately measure nutrient levels in breast milk.

Reference: Internet, medgadget, Senator Medical Ab

Keywords: Innovative technologies, future projects, Senator Medical AB, Medisenator, milk analyzer, 2019, FDA approved, Medical devices