FDA Clearance | Glytec

August 16, 2017

Glytec Announces Fourth FDA 510(k) Clearance for Its Market-Leading Diabetes Therapy Management Software

The company’s eGlycemic Management System® featuring Glucommander™ has the broadest indications for use of any decision support solution for insulin titration.

The pioneer of diabetes therapy management software, Glytec announces its fourth FDA clearance, adding a broad array of capabilities to Glucommander™, the core of its patented eGlycemic Management System®. As the first company to receive FDA clearance for an insulin titration decision support solution — a milestone that occurred in 2006, the year it was founded — Glytec continues to lead this critically important and evolving category of technology-enabled medication optimization.

May 22, 2012

Glytec Adds Pediatric Insulin Dosing to its IV and SubQ FDA Clearances

Glytec announced today that its Glucommander™ 2.0 Enterprise platform has been cleared by the FDA for pediatric use, ages 2 – 17.

Glytec’s Glucommander™ was the first insulin dosing software to be cleared for adult (ages 18+) intravenous use; it is the only company to achieve specific clearance for subcutaneous use, and now it is the only company cleared to offer this technology to hospitals caring for children.

July 20, 2010

Glytec Announces FDA 510(k) Clearance on G+ Enterprise Edition Insulin Dosing Software

Glytec announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its G+ System Enterprise Edition, the next generation of the industry standard sophisticated insulin management software system.

The system incorporates new innovative features including certain algorithm enhancements, additional predictive warning and alerts, a fully-integrated and real-time reporting engine, and precision bolus dosing of meal-time insulin. The Enterprise Edition software provides both intravenous and subcutaneous dosing recommendations of insulin and glucose and can be accessed from any computer within a hospital’s network.