FDA clears portable incubator for thermoregulation in preterm infants

mOm Incubators Limited announced that the FDA has granted 510(k) clearance for the mOm Essential Incubator, a portable device designed to provide thermoregulation for premature infants in a range of clinical settings. With this clearance, the company can market the device in the United States.¹

The company stated that FDA clearance was supported by safety and performance testing, including temperature control and biocompatibility assessments, and by demonstrated compliance with FDA regulations and IEC 60601 series standards.

According to the company, the mOm Essential Incubator is intended to address gaps in immediate neonatal care, particularly in labor and delivery units that do not have on-site neonatal intensive care units (NICUs). The device is designed to be used throughout the hospital and to remain close to parents as infants transition through postnatal care, while maintaining thermal support.

Approximately 400,000 premature births occur annually in the United States. Although more than 800 level III and level IV NICUs operate nationwide, many rural and semi-urban hospitals lack the capacity to provide immediate neonatal care that allows mother and infant to remain together. Neonatal hypothermia remains a common and preventable risk for preterm infants and is associated with increased morbidity and mortality. Thermal management is widely recognized as a critical component of neonatal care.¹

“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 [United States] 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 US hospitals and health care systems, whilst improving the overall patient and carer experience.”

The company noted that the device may be particularly relevant for hospitals in rural regions, where neonatal care unit closures over the past 15 years have limited access to specialized services. Anne Groves, MD, consultant neonatologist and founder of AEG Innovations, highlighted the potential impact in these settings.

“The [United States] 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,” Groves 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 as a single, energy-efficient system that can support thermal regulation from delivery through postnatal care. It can operate on multiple power sources and includes a backup battery capable of maintaining a set temperature for at least one hour on a single charge.

The device has prior clinical experience in the United Kingdom, where it received a Medical Device Regulation (MDR) CE mark and became commercially available in 2022. Multiple National Health Service hospitals have incorporated the incubator into neonatal care protocols. According to the company, a recent quality improvement project reported that hypothermia admissions to the NICU at Liverpool Women’s Hospital dropped to zero following implementation of the device, with additional sites reporting reduced respiratory distress in term and late preterm newborns.

Beyond high-resource settings, the company reported that the incubator is also being used in humanitarian emergencies and under-resourced environments.

“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,” said Joshua Boger, PhD, a member of the board of directors of mOm Incubators and an advisor to the company. “In the [united States], 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 US 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.”²

Reference

1. mOm Incubators Limited. mOm Incubators Receives FDA Clearance for First-of-Its-Kind Portable Incubator for Premature Babies. Businesswire. January 21, 2026. Accessed January 21, 2026. https://www.businesswire.com/news/home/20260121208393/en/mOm-Incubators-Receives-FDA-Clearance-for-First-of-Its-Kind-Portable-Incubator-for-Premature-Babies
2. March of Dimes. Nowhere to Go: Maternity Care Deserts Across the US. March of Dimes. 2024. Accessed January 21, 2026. https://www.marchofdimes.org/maternity-care-deserts-report