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U.S. ♦ FDA_모유 다량 영양 분석_진단 검사 측정 기기로_최초 승인 • Miris® HMA™ Human Milk Analyser
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2018-12-30 21:57
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Miris® receives US FDA De Novo clearance for the Miris® Human Milk Analyzer™
Miris® receives US FDA De Novo clearance for the Miris® Human Milk Analyzer™
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Miris receives US FDA De Novo clearance for the Miris Human Milk Analyzer™
With the company’s De Novo request now granted, the Miris Human Milk Analyzer™ (HMA) is the only approved device for macronutrient analysis of human milk on the US market
.
Press announcement
Miris HMA quantitatively measures the concentration of fat, carbohydrate and protein in human milk, and provides calculated values for total solids and energy. In conjunction with other clinical assessments, these measurements provide valuable knowledge for clinicians in the nutritional management of newborns, including preterm, and infants.
Take nutritional management in your NICU to the next level by gaining data on the macronutrient content in mother’s own milk and in donated breast milk.
Contact us to get your quote
Bringing neonatal care to the world
Swedish neonatal care ranks among the best in the world. More preterm babies grow up to become healthy kids in Sweden than in most other countries. Individualized nutrition through target fortification is one of the specific management routines used to ensure better recovery, growth, and cognitive outcome.
Miris is proud to be part of this tradition, which is built on years of experience and dedication. Giving every premature infant the best possible start in life is what inspires us and keeps us committed. We want to share our knowledge and engagement with the rest of the world to enable improved neonatal health.
2018-12-21 ♥
Miris® HMA™ Human Milk Analyser is cleared by FDA
FDA permits marketing of a diagnostic test to aid in measuring nutrients in breast milk.
Years of hard work has resulted in Miris being able to provide US healthcare professionals with a new tool to aid in the nutritional management of newborns and young infants at risk for growth failure due to prematurity or other medical conditions.
美 FDA 모유 다량 영양 분석 검사 측정기기 승인
모유 다량 영양소 측정:지방,조단백질,탄수화물,순단백질, 고형물질, 에너지, 계산
미국
FDA
에서 미리스(
Miris® HMA™ in Sweden
) 모유 영양 분석 측정
검사가 FDA
승인
을 받았다.
이는 조산 등의 원인으로 성장 부전 위험에 처한 신생아 및 영유아의 영양 관리를 돕기 위한 것이다
December 21,2018
Re : DEN18007
Trade/Device Name :Miris Human Milk Analyzer
Regulaton Number :21 CFR 862.1493
다운로드
DEN180007.pdf
다운로드
DEN180007.pdf
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