June 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.
Glytec, LLC, a wholly-owned subsidiary of GlucoTec, Inc., 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. This important treatment information is then fully-integrated with the hospital’s existing electronic medical record systems. The dosage recommendation and other patient data can also be made available through cloud-based, secure Internet platforms that eliminate the need for onsite servers and complicated installations.
“The introduction of this system marks a major advancement in the tools available to clinicians for the treatment of hyperglycemia. Being able to access a patient’s glycemic data across a network, the Internet, or a mobile device in real-time will have a significant impact on the improvement of patient outcomes and safety,” said Bruce Bode, MD, FACE, a member of the Board of the company and a leading diabetes specialist.
About Glytec, LLC
Glytec, LLC, is a privately held company based in Greenville, South Carolina. The company’s first generation glycemic management system, using point-of-care touch screen interfaces, received FDA 510(k) clearance in May 2006, and was launched as a commercial product in January 2007. For more information about Glytec, please visit www.glytecsystems.com. The published Indications for Use of the G+™ System as a prescription device are described on the FDA’s website under Reference K101344.
Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes or benefits are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, ultimate clinical outcomes and benefit of the Company’s products to patients, market and physician acceptance of the products, intellectual property protection and competitive product offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements.