mOm Incubators Receives FDA Clearance for First-of-Its-Kind Portable Incubator for Premature Babies

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NOTTINGHAM, England--(BUSINESS WIRE)--Jan 21, 2026--

mOm Incubators Limited announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s mOm Essential Incubator, a first-of-its-kind portable incubator that provides thermoregulation for premature babies, to market the device in the United States. The novel design of the mOm Essential Incubator enables it to be used anywhere and everywhere, and enables mother and baby to stay together, reducing parental stress and improving health outcomes. mOm Incubators Limited will work with Health Care Providers (HCPs) to deploy mOm Essential Incubators across a range of labor and delivery settings across the United States, enabling more rapid access to neonatal care and maintaining the closeness of newborn and mother.

There are approximately 400,000 premature births each year in the United States, and the U.S. has more than 800 neonatal intensive care units (NICUs) that are Level III or Level IV. However, many rural and semi-urban labor and delivery units lack the ability to provide immediate and safe neonatal care for premature babies that can enable mother and baby to stay together. 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.

“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.”

“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.”

mOm delivers flexible, clinically effective neonatal care across multiple healthcare settings using a single, energy-efficient device to help prevent hypothermia from delivery through post-natal care. The mOm Essential Incubator can be used in any part of the hospital and remain close to the parents as they move forward in their postnatal journey, without compromising on effectiveness or health standards. The mOm Essential Incubator is able to work off multiple power sources and includes a back-up battery that can maintain a set temperature for at least one hour on a single charge.

Clinical Experience with mOm Essential Incubators in the United Kingdom

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. Results from a recent Quality Improvement project showed that hypothermia admissions to the NICU at Liverpool Women’s Hospital dropped to zero following implementation of mOm Incubators, and other sites within the trust saw reduced incidence of respiratory distress, in term newborns and late preterm newborns, whilst keeping parents closer to their baby, promoting bonding and improving the patient experience.

The mOm Essential Incubator is also being deployed to save the lives of premature babies in humanitarian emergencies and situations across the globe.

“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, Ph.D., a Member of the Board of the Directors of mOm Incubators Limited, and an Advisor to the Company. “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.”

Clearance in the U.S. was based on extensive safety and performance testing, including controlling temperature, and biocompatibility testing, together with demonstration of compliance with FDA regulations, including IEC 60601 series standards.

About mOm Incubators Limited

mOm’s vision is simple: every child deserves the best start in life. Their first product, the mOm Essential Incubator, was developed in the UK with input from clinicians across the globe. It is CE-marked and has been deployed both in high-resource settings like the NHS and in some of the most difficult environments globally, including in crisis zones. mOm estimates it has already impacted over 12,000 babies with its device.

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CONTACT: For more information, please contact: mOm Incubators Ltd

Tel. +44 (0) 115 671 6016; email:[email protected]; Web:momincubators.com

KEYWORD: UNITED KINGDOM EUROPE

INDUSTRY KEYWORD: NURSING MEDICAL DEVICES HOSPITALS FDA BABY/MATERNITY HEALTH TECHNOLOGY OTHER HEALTH MANAGED CARE CONSUMER HEALTH

SOURCE: mOm Incubators Limited

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PUB: 01/21/2026 08:00 AM/DISC: 01/21/2026 08:00 AM

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