Admetsys Announces FDA's Breakthrough Designation for Automated Glucose Control and Continuous Blood Diagnostics System
Admetsys Corporation, a biomedical technology firm specializing in critical care automation, recently announced that its automated glucose control and continuous blood diagnostics system has been granted Breakthrough Device designation by the FDA. This recognition paves an expedited path for the system's introduction to the United States market, particularly in an environment where cardiometabolic disorders dominate critical care, and hospitals grapple with mounting challenges such as nursing shortages, rising patient demands, and a growing emphasis on equitable access to high-quality care.
The Admetsys system addresses a significant gap in the current standard of care by automatically monitoring multiple blood analytes, including glucose, in real-time without requiring any blood loss from patients. It then utilizes this data to create a dynamic computational model of each patient's metabolism, adapting as the patient's condition evolves. This innovative approach allows the system to provide highly precise treatment through its multiple infusion channels, delivering insulin and dextrose as needed.
The FDA's Breakthrough Device designation is not easily obtained. To qualify, a medical device must demonstrate its ability to offer more effective treatment for life-threatening or irreversibly debilitating conditions, represent a true breakthrough in technology, offer substantial advantages over existing alternatives, and prioritize the best interests of patients. This Breakthrough Device designation signals a promising future for healthcare, providing hope for improved outcomes and patient experiences in the face of life-threatening conditions.