Monarch Medical Technologies has received U.S. Food and Drug Administration (FDA) 510(k) clearance of its newest solution, EndoTool SubQ.

“The FDA 510(k) Clearance of our newest solution comes at a critical time for hospitals and for Monarch. Today, more patients than ever require insulin during their hospitalizations. While insulin remains one of the most dangerous drugs to dose, our EndoTool platform provides proven outcomes, giving confidence to the caregivers that they will provide the safest intravenous and subcutaneous insulin therapy for their patients,” said Dave MacCutcheon, vice president of Product Management at Monarch.

Incorporating an advanced proprietary technology, EndoTool SubQ uses feedback mathematics for modeling, predicting, and recommending subcutaneous insulin and carbohydrate doses.

Individualized recommended doses are administered subcutaneously by the bedside caregiver to manage blood glucose levels in both adult and pediatric patients (age 2 years and above). Healthcare organizations have full control of clinical parameters and goal ranges based on internal protocols and compliance requirements. As a part of the EndoTool platform, patients can be transferred safely and easily between intravenous and subcutaneous insulin therapies, company executives said.

“We strive to be the safest solution for dosing insulin to patients and to facilitate the trust between patients and caregivers,” said Stuart Long, CEO at Monarch. “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 Medical Technologies is a privately held medical technology company focused on improving hospital-based glucose management. The company is based in Charlotte, N.C.

Watch the video below for details on model predictive control technology: