Medical device firm Invictus Medical has obtained approval from the US Food and Drug Administration (FDA) for its GELShield extracranial pressure relief device.
The approval has been granted for the device to relieve extracranial pressure due to prolonged immobility.
Invictus Medical board of directors chairman Steve Dufilho said: "Our mission is to secure healthy early development milestones in newborns by providing innovative products, services and solutions to the healthcare professional and consumer markets.
The FDA approval allows the company to market the device, which has completed a comprehensive safety validation study at the Baylor University Medical Centre in Dallas.
Invictus Medical president and CEO Tom Roberts said: "FDA clearance of the GELShield is a major strategic milestone in that effort and we expect to begin seeing this breakthrough product in use in neonatal intensive care units in the very near future."
Established in 2012, the company is involved in developing paediatric solutions.