Glytec said today that it won a fourth 510(k) clearance from the FDA for its insulin titration software, eGlycemic Management System featuring Glucommander.
The latest FDA nod applies to product enhancements derived from user feedback, the Waltham, Mass.-based company said, including a streamlined transition of inpatients from IV to subcutaneous therapy and more robust workflow capabilities.
The company’s technology is designed to support the IV and subcutaneous delivery of long-acting basal insulins, rapid-acting analogues and regular insulin. Dosing recommendations given by Glucommander are personalized to individual patients, Glytec reported, and are adjusted based on glucose history and other variables.
Glytec touts its cloud-hosted eGlycemic Management System and Glucommander as a way for providers to standardize care and support best practices for diabetes patients.
“We’ve come a long way since we first went to market in 2006 with our Glucommander IV solution,” SVP of R&D Robby Booth said in prepared remarks. “We’ve continued to innovate and respond to the needs of our clients. Now, with diabetes reaching epidemic levels and costs spiraling out of control, one of every three Medicare dollars is spent on diabetes care, not only is demand for Glucommander and the whole of our eGMS growing exponentially, providers are asking us to continue expanding our digital solutions portfolio and assist them in conquering the challenges of managing non-insulin therapies. We are well down the road in the development of our Therapy Advisor and fulfillment of our vision to become the medication optimization company for all diabetes medications.”
“We have fundamentally built a technology category from the ground up, and this latest FDA clearance demonstrates our steadfast commitment to continuous innovation,” president & CEO Bob Leonard added. “Glytec’s platform provides substantive value to healthcare organizations and their patients, markedly improving safety while producing annualized savings as high as $20,000 per licensed bed in the acute care setting and $2,470 per patient from a chronic care perspective. Glytec offers providers and payers the opportunity to uniquely address a significant unmet need as they look to create more proactive, population-based and personalized approaches to diabetes care.”
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