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

The mOm Essential Incubator’s design lets it be used in a variety of settings and lets mother and baby stay together. The company will work with healthcare providers to deploy the incubators across a range of labor and delivery settings in the U.S., enabling more rapid access to neonatal care.

Neonatal hypothermia is a risk for the vast majority of preterm babies, and is one of the most avoidable threats to neonatal health even in modern healthcare systems. Effective thermal management practices are recognized globally as critical to reducing infant morbidity and mortality.

mOm uses a single, energy-efficient device to prevent hypothermia from delivery through post-natal care. The incubator can be used in any part of the hospital and remain close to the parents as they move forward in their post-natal journey. It can work off multiple power sources and includes a backup battery that can maintain a set temperature for at least an hour on a single charge.

The mOm Essential Incubator received an MDR (EU) CE mark and became commercially available in the UK and Europe in 2022. Multiple NHS hospitals are implementing mOm Incubators into their neonatal care protocols to help reduce the need for short-term admission to Special Care for hypothermia and to help maintain the core temperature of babies being moved around hospital sites.

The incubator is also being used to save premature babies in humanitarian emergencies and situations around the world.

“The U.S. has experienced a wave of closures of neonatal care units over the last 15 years, and this has made high-quality care for premature babies more difficult to access,” said Anne Groves, M.D., Consultant Neonatologist and Founder of AEG Innovations. “The mOm incubator offers an innovative way to address a key gap for labor and delivery units in many rural and semi-urban hospitals, by reducing the number of babies that need to be moved—sometimes long distances—to a NICU, and by avoiding the trauma of separating mother and baby.”

“Since we first started deploying the mOm Essential Incubator into labor and delivery settings, it has been incredibly gratifying to see the impact of this device in reducing complications and improving babies’ lives, and at the same time keeping parents closer to their newborn, which ultimately is what every parent wants when they bring a new life into the world,” said James Roberts, CEO, and inventor of the mOm Essential Incubator. “Becoming commercially available in the U.S. is a major step towards more widespread adoption of our technology. The mOm Essential Incubator is poised to deliver outstanding clinical benefit and economic value within multiple U.S. hospitals and health care systems, whilst improving the overall patient and carer experience.”