Monarch Medical Technologies Announces FDA Clearance of EndoTool IV 3.1 with Dosing Mode For Hyperglycemic Crisis Management

Strengthening Hospital Response to Hyperglycemic Crisis: EndoTool may be used in the treatment of hyperglycemic crises, including conditions such as Euglycemic DKA (EuDKA), DKA, and HHNK.

Monarch Medical Technologies, the only patient-specific insulin dosing solution for hospitals, today announced FDA 510(k) clearance of EndoTool® IV 3.1, which includes the introduction of EndoX 3 – a new mode designed to enhance insulin dosing recommendations for patients experiencing hyperglycemic crises, including conditions such as Euglycemic Diabetic Ketoacidosis (EuDKA), Diabetic Ketoacidosis (DKA), and Hyperglycemic Hyperosmolar Nonketotic Syndrome (HHNK).

With hyperglycemic emergencies becoming more complex and difficult to manage, the new mode helps clinicians deliver timely, patient-specific insulin therapy when traditional protocols may be insufficient.

Although the clearance was granted in December 2024, Monarch prioritized a phased rollout and clinical education effort before formally announcing the advancement to the broader market.

“Clinicians are facing an increasing number of cases where traditional insulin protocols don’t fit – and timing is critical,” said Charles Cornish, Chief Executive Officer of Monarch Medical Technologies.

“This advancement gives providers and nurses a purpose-built tool to help them make safe, faster dosing decisions in high-risk situations like Euglycemic DKA. It’s about giving frontline teams more confidence when it matters most.”

With the addition of this new dosing mode, EndoTool may be used to support insulin dosing recommendations for patients experiencing a variety of hyperglycemic emergencies, including emerging clinical challenges like Euglycemic DKA.

The system dynamically adjusts dosing based on real-time blood glucose levels, renal function, and estimated residual insulin (EREI).

“From a regulatory standpoint, this clearance provides hospitals with additional confidence,” said Tara Burnett, Senior Vice President of Regulatory Affairs and Compliance.

“Rather than adapting existing protocols for complex cases, providers can now use EndoTool’s EndoX 3 mode to support individualized insulin dosing in clinical scenarios such as EuDKA, DKA, and HHNK.”

EndoTool has long differentiated itself through patient-specific dosing features and the use of predictive modeling, helping healthcare providers improve safety outcomes by minimizing the risk of hypoglycemia.

“Managing patients with conditions like EuDKA requires more precision and adaptability than traditional approaches offer,” said Dr. Paul Chidester, Chief Medical Officer at Monarch Medical Technologies.

“EndoX 3 empowers clinicians with clinical decision support that reflects the complexity of today’s inpatient population and supports safer insulin therapy.”

Key Highlights:

• FDA-cleared expansion of EndoTool IV to include new dosing mode that may be used in the treatment of hyperglycemic crises, including Euglycemic DKA, DKA, and HHNK
• EndoTool may also be used in other clinical scenarios where control of hyperglycemia requires an intravenous insulin infusion
• Real-time, patient-specific dosing incorporating glucose levels, renal function, and estimated residual insulin
• Supports safer insulin therapy in complex and high-risk inpatient populations

About Monarch Medical Technologies

Monarch Medical Technologies is the pioneer and leader in patient-specific insulin dosing software. Trusted by 8 of the top 10 U.S. health systems, EndoTool® delivers precise insulin recommendations that improve safety, reduce variability, and virtually eliminate severe hypoglycemia across inpatient settings.

To learn more about EndoTool, visit www.monarchmedtech.com.