Monarch Medical Receives FDA 510(K) Clearance for Endotool SubQ

EndoTool SubQ Utilizes Clinically Proven and Patent Pending Model Predictive Control Technology to Determine the Safest Patient-Specific Basal/Bolus and Correction Subcutaneous Insulin Dose Recommendations

CHARLOTTE, N.C.--(BUSINESS WIRE)--Monarch Medical Technologies, a medical technology company committed to safe insulin dosing, today announced that the US Food and Drug Administration (FDA) has cleared the company’s newest solution, EndoTool SubQ™.

“We strive to be the safest solution for dosing insulin to patients and to facilitate the trust between patients and caregivers”

“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,” says 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.

“We strive to be the safest solution for dosing insulin to patients and to facilitate the trust between patients and caregivers,” says Stuart Long, Chief Executive Officer 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.”

About Monarch Medical Technologies

Monarch Medical Technologies is a privately held medical technology company founded by clinicians with a vision of improving hospital-based glucose management. Providing the safest option in the market, Monarch is replacing traditional linear protocols with individualized and predictive computer-based solutions. With the launch of its flagship product, the EndoTool Glucose Management System, the company pioneers the field of predictive therapeutic control technologies for managing dangerous drugs and highly complex clinical protocols.

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