Monarch Medical Technologies Wins FDA Nod for EndoTool SubQ
Monarch Medical Technologies’ EndoTool SubQ insulin dosing platform has gained FDA approval, the Charlotte, N.C., devicemaker announced Wednesday.
The platform uses feedback mathematics to model, predict and recommend glucose dosing for adult and pediatric patients ages 2 and older, providing individualized recommendations for insulin and carbohydrate dosages, the company says.
Patients can then be transferred from intravenous to subcutaneous insulin treatments as needed, a delivery upgrade from the company’s EndoTool IV glucose management system, which can recommend therapy only through an IV.
The devicemaker plans to pursue CE Mark approval of the platform. — Jason Scott