BOSTON, Sept. 6, 2023 /PRNewswire/ -- Admetsys Corporation, a biomedical technology company specializing in critical care automation, announced today that the FDA has designated its automated glucose control and continuous blood diagnostics system a Breakthrough Device. This designation accelerates the system's path to market in the United States, where cardiometabolic disorder dominates critical care, and hospitals face increasing pressures from nursing shortages, escalating demand, and emphasis on equal access to high-quality care.
The system fills a key gap in the standard of care. It automatically measures multiple blood analytes, including glucose, in real time with no patient blood loss. From this, it creates an adaptive, computational model of each patient's metabolism, evolving as patient condition does, and delivers precisely optimized treatment of insulin and dextrose using its multiple infusion channels.
"The core of the system is its patient-adaptive learning algorithm. Machine intelligence using real-time biosensing data directly drives therapeutic actuation," says Admetsys CEO Jeff Valk. "This represents a new generation of device: fully autonomous clinical robotics."
To date, the limiting factor has been manual workflow. Metabolic parameters can change rapidly in critical care patients—often in minutes. Capturing and modeling variability accurately in real time is prohibitively difficult to do by hand, without which therapy is approximate and carries considerable clinical risk. These challenges are further compounded by scale of the need: 80% of critical care patients experience metabolic instability and risk from glucose dysregulation.
Correctly controlling glucose speeds healing at the tissue level, which is particularly decisive for recovery in cardiovascular and surgical patients. It decreases complications and increases survivability.
"The system unlocks a previously unachievable mode of care. It affects this economically, at scale, while preserving focus for clinicians," says Valk. "Precision automation fundamentally changes the equation."
About FDA Breakthrough designation:
To qualify as a Breakthrough product under FDA guidelines, a medical device must provide more effective treatment of a life-threatening or irreversibly debilitating condition, represent a breakthrough technology, offer significant advantages over any existing alternatives, and/or be in the best interest of patients.
Admetsys, headquartered in Boston, is a medical technology company specializing in critical care automation. The company's flagship PrecisionOne system is the first fully automated glycemic control system and continuous blood diagnostics platform for hospital care. The company was founded to commercialize the next generation of medical automation technology: continuous real-time biosensing, robotics, artificial intelligence and learning algorithms, intelligent therapeutic delivery, and advanced data telemetry.