FDA clears portable neonatal incubator designed to keep mothers and premature babies together

mOm Incubators Limited said Tuesday that the U.S. Food and Drug Administration has granted 510(k) clearance for its mOm Essential Incubator, a portable neonatal incubator designed to provide thermoregulation for premature babies and allow mothers and newborns to remain together.

The clearance allows the company to market the device in the United States. The mOm Essential Incubator is designed for use across multiple labor and delivery settings, including hospitals that lack on-site neonatal intensive care units, with the goal of improving access to immediate neonatal care and reducing the need to separate infants from their parents.

There are about 400,000 premature births each year in the United States, and while the country has more than 800 Level III and Level IV neonatal intensive care units, many rural and semi-urban hospitals lack the resources to provide advanced neonatal care immediately after birth. Neonatal hypothermia remains one of the most common and preventable risks for preterm infants, even in modern health care systems, and effective thermal management is widely recognized as critical to reducing infant illness and death.

“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.”

Anne Groves, M.D., a consultant neonatologist and founder of AEG Innovations, said access to neonatal care has become more challenging as units have closed. “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,” she said. “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.”

The mOm Essential Incubator is designed to be energy efficient, operate on multiple power sources and include a backup battery capable of maintaining a set temperature for at least one hour. U.S. clearance was based on safety and performance testing, including temperature control, biocompatibility and compliance with FDA and IEC 60601 standards.

Advances in neonatal incubator technology and care

Recent years have seen significant advances in neonatal care technology, particularly in the design of incubators and warming systems aimed at preventing hypothermia and reducing complications in premature and vulnerable newborns. Traditional incubators have long been confined to NICU settings, requiring infants to be transported away from labor and delivery units and often separated from their parents shortly after birth. Newer approaches are focused on mobility, continuity of care and family-centered design.

Portable and hybrid incubator systems are increasingly being developed to bridge gaps between delivery rooms, postnatal wards and intensive care units. These devices emphasize precise thermal regulation, ease of cleaning and infection control, and the ability to function reliably during transport within hospitals or between facilities. Advances in battery technology and energy efficiency have made it possible for incubators to maintain stable temperatures without constant access to wall power, a feature that is particularly important in rural hospitals and emergency situations.

In parallel, there has been growing recognition of the clinical and psychological benefits of keeping mothers and newborns together whenever possible. Research has linked skin-to-skin contact and early bonding to improved breastfeeding rates, better temperature stability and reduced stress for both infants and parents. As a result, neonatal technologies are increasingly being designed to support these practices rather than disrupt them.

Global health and humanitarian applications have also influenced innovation in this sector. Devices intended for use in low-resource settings must be durable, simple to operate and adaptable to inconsistent power supplies, lessons that are now being applied more broadly in high-income health systems. At the same time, quality improvement initiatives in hospitals have demonstrated that better thermal management can reduce admissions to intensive care and lower rates of respiratory distress and other complications.

Joshua Boger, Ph.D., a board member of mOm Incubators Limited, said such innovations can have wide-reaching effects. “The mOm Essential Incubator is a highly versatile innovation, capable of delivering improvements in clinical outcomes in established healthcare systems as well as saving babies’ lives in underresourced economies and areas impacted by armed conflict,” he said. “In the U.S., there are multiple areas where we see the mOm Incubator having a transformational impact, including increasing access to quality neonatal care in rural areas—35% of U.S. counties are considered to be ‘maternity care deserts’—and significantly reducing the rate of admission or transfer to NICU, which will enable mothers and newborns to stay together.”