The U.S. Food and Drug Administration (FDA) has cleared the EndoTool IV from Monarch Medical Technologies. The technology is part of the Charlotte, N.C.-based firm's glucose-management software platform.
The tool tracks glucose in the blood of hospitalized patients, which allows for customization of insulin dosing.
Management of patients suffering from acute-glycemic crisis states often requires the precise introduction of fluids, electrolytes and insulin to avoid further complications. The software facilitates care for patients with elevated levels of residual extracellular insulin and includes pediatric-dosing capability and an Intranet cloud-based option.
“The mission of Monarch Medical Technologies is to transform the way drugs of concern are dosed and processes of concern are handled in a hospital setting,” said Dr. Wilson Constantine, the firm's CEO. “EndoTool IV is the first step in a larger strategic plan to harness our proprietary model predictive control technology platform and provide 360-degrees of glycemic control for patients.”
The EndoTool system works by constantly calculating how much insulin is needed based on a patient’s unique physiology and individual response. EndoX, a function within the new system, is a proprietary customization module that allows healthcare providers to structure dosing and clinical decision support messages to reinforce best practices for insulin dosing in the treatment of patients experiencing acute glycemic crisis states. Management of such conditions often requires the precise and regulated introduction of fluids, electrolytes and insulin to avoid further complications.
The amount of residual extracellular insulin present in a person’s body is another important variable that must be taken into account to achieve correct insulin dosing, maintain glucose control and avoid hypoglycemia. EndoTool IV helps account for this by offering estimated residual extracellular insulin (or EREI) functionality to ensure proper patient-specific dosing. If the patient has more residual extracellular insulin than can be supported by circulating glucose, EndoTool IV can adapt the dosing recommendations, and if desired, recommend a counter-balancing dextrose dose.
“Monarch is committed to providing the ultimate customer care experience, and we have taken great care in developing EndoTool IV, including optimal design for improved efficiency in the user interface,” Constantine added. “In addition to enhanced EndoX and EREI functionality, the pediatric dosing capability and a private intranet cloud-based option make EndoTool IV the most comprehensive and powerful glucose management system on the market.”
The company expects to launch EndoTool IV commercially in June, with another component to be submitted to the FDA later this year. Company officials noted that the software was developed based on requests from healthcare professionals.
Privately held Monarch Medical Technologies had been the EndoTool division of Hospira. It was acquired in September 2012 by private-equity firm Eigen Capital of Palo Alto, Calif.