FDA grants breakthrough designation to Glytec’s Glucommander Pediatrics

The US FDA has granted breakthrough device designation to Glytec’s proposed insulin dosing recommendation algorithm, Glucommander Pediatrics, for hospitalised newborns and infants under two years old. The proposed prescription-only product would be separate from Glytec’s existing Glucommander technology. Hyperglycaemia is common among ill newborns and premature infants and is associated with poor outcomes in this patient group. Credit: Yuriy K / Shutterstock.com. The US Food and Drug Administration (FDA) has granted breakthrough device designation to Glytec’s proposed insulin dosing recommendation algorithm, Glucommander Pediatrics, for hospitalised newborns and infants under two years old. The algorithm is intended for neonates and infants…

Source: Medical Device Network