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Home » mOm Incubators wins FDA nod for first-of-its-kind portable incubator

mOm Incubators wins FDA nod for first-of-its-kind portable incubator

January 21, 2026 By Sean Whooley

mOm Incubators Essential Incubator
The Essential Incubator system. [Image courtesy of mOm Incubators]
mOm Incubators announced today that the FDA granted 510(k) clearance for its Essential Incubator system.

The first-of-its-kind portable incubator provides thermoregulation for premature babies. Its novel design enables use anywhere, allowing mother and baby to stay together, reducing parental stress and improving health outcomes.

mOm plans to work with healthcare providers to deploy its incubators across a range of U.S. labor and delivery settings. It hopes to enable more rapid access to neonatal care and maintain the closeness of newborn and mother.

The Essential Incubator operates as a single, energy-efficient device that helps prevent hypothermia from delivery through post-natal care. It can work in any part of the hospital and remain close to parents without compromising on effectiveness or health standards. The system also works off multiple power sources and has a back-up battery that can maintain a set temperature for at least one hour on a single charge.

mOm’s Essential Incubator already has CE mark and has been available in the UK and Europe since 2022.

“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 US 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.”

Filed Under: 510(k), Food & Drug Administration (FDA), Hospital Care, Pediatrics, Regulatory/Compliance Tagged With: FDA, mOm Incubators

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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