mOm Incubators Limited announced 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.
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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.
