NeoLight, located in Phoenix, Arizona, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration to market the Skylife™ portable phototherapy system. The Skylife device delivers a narrow band of high-intensity blue light via blue light emitting diodes to provide treatment for neonatal unconjugated hyperbilirubinemia (jaundice).
NeoLight Co-Founder and CEO Vivek Kopparthi comments: “We are thrilled to have 510(k) clearance for the Skylife phototherapy system and see this as a key milestone in our mission to reinvent the newborn care space through empathy-driven innovation.” Kopparthi concluded, “Our approach always starts with one question – what is best for the baby? This question drives everything we do.”
Infant jaundice occurs when a baby’s blood contains an excess of bilirubin, a byproduct of red blood cells. Neonatal jaundice is a common condition, particularly in babies born before 38 weeks gestation (preterm babies). Jaundice in the newborn must be carefully monitored, as although complications are rare, a high bilirubin level associated with severe infant jaundice or inadequately treated jaundice may cause brain damage. Jaundice occurs in approximately 60% of the 4 million neonates born yearly in the United States