MOm Incubators Receives FDA Clearance for first-of-its-kind Portable Neonatal Incubator

mOm Incubators Limited has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its mOm Essential Incubator, a first-of-its-kind portable incubator for premature babies.

The device provides thermoregulation and can be used anywhere within a hospital, allowing mothers and babies to stay together, reducing parental stress and improving health outcomes. 

The company plans to deploy the incubators across a variety of labour and delivery settings in the United States, including rural areas, to increase access to immediate neonatal care.

The mOm Essential Incubator addresses the risk of neonatal hypothermia, one of the most preventable threats to premature infants. 

It operates from multiple power sources and includes a backup battery capable of maintaining the target temperature for at least one hour. 

Its design allows flexible use across the hospital while keeping babies close to their parents, supporting bonding without compromising care standards.

The device has already been commercially available in the UK and Europe since 2022, where implementation in NHS hospitals has reduced hypothermia admissions and improved outcomes for preterm and term newborns. 

The incubator is also being used in humanitarian and emergency settings worldwide to provide life-saving neonatal care.

FDA clearance was granted following extensive safety and performance testing, including temperature control, biocompatibility, and compliance with relevant regulations and standards.