Thursday, September 07, 2023
Admetsys Corporation, a leading biomedical technology firm specializing in critical care automation, has announced that the FDA has granted its automated glucose control and continuous blood diagnostics system the prestigious Breakthrough Device designation.
This significant recognition expedites the system's introduction to the U.S. market, addressing the challenges encountered by hospitals dealing with cardiometabolic disorders, staffing shortages, surging patient numbers, and the imperative of providing equitable access to top-notch healthcare.
The system effectively bridges a critical gap in the existing standard of care. It autonomously monitors multiple blood analytes, including glucose, in real-time without the need for blood withdrawal from patients. Leveraging this data, it constructs an adaptable computational model of each patient's metabolism, adapting dynamically as the patient's condition evolves. Subsequently, the system administers precise, optimized treatments involving insulin and dextrose via its multiple infusion channels. At the heart of this system lies its patient-adaptive learning algorithm, which utilizes real-time biosensing data to directly inform therapeutic interventions.
One of the primary challenges in critical care has been the reliance on manual workflows. Metabolic parameters in critical care patients can exhibit rapid fluctuations, sometimes changing within minutes. The accurate capture and real-time modeling of this variability through manual means are exceptionally challenging, and without this capability, therapy remains approximate and carries significant clinical risks. These challenges are exacerbated by the widespread prevalence of metabolic instability and glucose dysregulation, affecting around 80% of critical care patients.
In accordance with FDA guidelines, a medical device must fulfill specific criteria to be designated as a Breakthrough Device. This includes demonstrating superior efficacy in treating life-threatening or irreversibly debilitating conditions, representing a groundbreaking technological advancement, offering substantial advantages over existing alternatives, and, most importantly, being in the best interest of patients.
Source: prnewswire.com
