U.S ♦.FOOD & DRUG FDA Miris® HMA™ 모유 다량 영양 분석 진단 측정 표준 검사기기로 공식 승인-

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Re: DEN180007
Trade/Device Name: Miris Human Milk Analyzer
Regulation Number: 21 CFR 862.1493
Regulation Name: Breast milk macronutrients test system
Regulatory Class: Class II
Product Code: QEI
Dated: October 24, 2018
Received: October 24, 2018

The Miris HMA™ was cleared by FDA in the end of December 2018. Soon after the company received a request from the Wake Forest Baptist Health NICU and they subsequently became the first NICU in US with the FDA cleared version of the Miris HMA™. Over a year down the road we checked in with Doctor Amit Chandel, Assistant Professor of Pediatrics, to hear how the Miris HMA™ has improved the nutritional care of their smallest babies

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美 모유 영양 분석 검사 승인-다량 영양소 측정, 고형 성분 및 에너지,탄수화물 계산

2018.12.21. 자 NEWS

미국 FDA 에서 미리스(Miris® HMA™ in Sweden ) 모유 영양 분석 측정 검사가 FDA 승인을 받았다. 이는 조산 등의 원인으로 성장 부전 위험에 처한 신생아 및 영유아의 영양 관리를 돕기 위한 것이다.

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.

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Miris receives US FDA De Novo clearance for the Miris Human Milk Analyzer™

Bringing neonatal care to the world