The Food and Drug Administration gave a green signal to Natus Medical’s Cool-Cap device since more than 5000 babies in the US are born yearly with moderate to severe hypoxic-ischemic encephalopathy (HIE) and this new cap would cool the heads of babies in order to avoid brain damage.
The Cool-Cap system is developed by privately held Olympic Medical it sends a uniform flow of cool water through a cap placed on baby’s head.
The FDA approval is based on a study of 234 infants deprived of oxygen at birth. At 18 months, babies treated with the Cool-Cap had lower rates of death and severe disability than infants who received standard supportive care.
