Monarch Medical Technologies has received 510(k) approval from the US Food and Drug Administration (FDA) for its new EndoTool SubQ.
Integrating an advanced proprietary technology, the new solution uses feedback mathematics for modeling, predicting, and recommending subcutaneous insulin and carbohydrate doses.
The bedside caregiver will administer the individualised recommended doses subcutaneously to manage blood glucose levels in both adult and pediatric patients, aged two years and above.
Monarch said that the patients can be transferred safely and easily between intravenous and subcutaneous insulin therapies, as part of the EndoTool platform.
Monarch Medical Technologies CEO Stuart Long said: "The addition of our SubQ product enhances the value of our EndoTool platform and provides our clients the ability to uniquely provide patient-specific and safe treatment of patient types requiring insulin therapy.
"We are very excited to announce the approval of our EndoTool SubQ solution, and to be the catalyst that healthcare needs in order to provide the safest care with insulin dosing."
Monarch is a privately held medical technology, which also produces EndoTool glucose management system.