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Breakthrough

Glytec wins Breakthrough designation for insulin dosing software in newborns

MedDevice Startups Staff · 23 hrs ago · 2 min read · Via PR Newswire

FDA granted Breakthrough Device designation to Glytec's Glucommander Pediatrics on September 24. The software calculates insulin infusion rates for hospitalized patients from birth to under 2 years of age.

No insulin dosing software is cleared for that age group today. The designation covers diabetic ketoacidosis, hyperglycemic hyperosmolar state, hyperglycemia of prematurity, and persistent hyperglycemia in critically ill infants in intensive care.

The adult Glucommander cleared in 2006 and runs in more than 400 hospitals and health systems. Glytec, based in Atlanta, extended it to ages 2 through 17 in 2012. Breakthrough buys sponsor meetings and priority review attention, which is worth most where there is no predicate and the population is small enough that enrollment is the binding constraint.

Questions & Answers

What is Glytec Glucommander Pediatrics?

Glucommander Pediatrics is Glytec's insulin dosing recommendation algorithm for hospitalized neonates and infants from birth to under 2 years of age. FDA granted it Breakthrough Device designation on September 24, 2026.

Which conditions does the Glytec Breakthrough designation cover?

The Breakthrough Device designation for Glytec Glucommander Pediatrics covers diabetic ketoacidosis, hyperglycemic hyperosmolar state, hyperglycemia of prematurity, and persistent hyperglycemia in critically ill infants receiving intensive care.

Is there any FDA-cleared insulin dosing software for newborns?

No. Glytec says no insulin dosing software is currently FDA cleared for patients from birth to under 2 years. Glytec's adult Glucommander cleared in 2006 and the company extended it to ages 2 through 17 in 2012.

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