21/01/2026
We’re proud to share a major milestone for mOm Incubators
mOm Incubators has received FDA 510k clearance for the mOm Essential Incubator: a first-of-its-kind portable incubator designed to provide safe thermoregulation for premature babies while keeping mother and baby together.
With approximately 400,000 premature births each year in the US, access to immediate neonatal care remains uneven - particularly in rural and semi-urban settings. The mOm Essential is designed to help close this gap by enabling effective neonatal care anywhere and everywhere, while reducing unnecessary NICU admissions and avoiding the trauma of separation.
Already in use across hospitals in the UK where it has helped reduce hypothermia-related NICU admissions to zero in some settings, FDA 510k clearance marks a significant step toward expanding access to this life-saving innovation in the United States.
Every child deserves the best start in life, and this is just the beginning.
For more information: https://shorturl.at/VGhET